N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Study identifier:CD-IA-MEDI-551-1155

ClinicalTrials.gov identifier:NCT02200770

EudraCT identifier:2014-000253-36

CTIS identifier:N/A

Study Complete

Official Title

A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.

Medical condition

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Phase

Phase 2/3

Healthy volunteers

Study drug

Inebilizumab

Sex

All

Actual Enrollment

231

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Apr 2015

Primary Completion Date: 26 Oct 2018

Study Completion Date: 06 Nov 2020

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2021 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1.Men and women 18 years or older with diagnosis of NMO/NMOSD
2.Confirmation of NMO/NMOSD status:
a.AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
b.AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
3.Able and willing to give written informed consent and comply with the requirements of the study protocol.
4.EDSS <= 7.5 (8 in special circumstances)
5.Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.

Exclusion Criteria

1.Lactating and pregnant females
2.Treatment with any investigational agent within 4 weeks of screening
3.Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
4.Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
5.History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
6.Receipt of the following at any time prior to randomization:
a.Alemtuzumab
b.Total lymphoid irradiation
c.Bone marrow transplant
d.T-cell vaccination therapy
7.Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
8.Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization.
9.Receipt of any of the following within 3 months prior to randomization:
a.Natalizumab (Tysabri®).
b.Cyclosporin
c.Methotrexate
d.Mitoxantrone
e.Cyclophosphamide
f.Tocilizumab
g.Eculizumab
10.History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
11.Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection
12.History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization
13. Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days

Location

Research Site

Katowice, Poland, 40-595

Location

Research Site

Varna, Bulgaria, 9010

Location

Research Site

Changhua City, Taiwan, Province of China, 50006

Location

Research Site

San Luis Potosi, Mexico, 78090

Location

Research Site

Madrid, Spain, 28040

Location

Research Site

Khabarovsk, Russian Federation, 680009

Location

Research Site

Belgorod, Russian Federation, 308007

Location

Research Site

Moscow, Russian Federation, 127018

Arms	Assigned Interventions
Placebo Comparator: Placebo/Inebilizumab Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.	Drug: Inebilizumab Participants will receive IV inebilizumab 300 mg. Other Name: MEDI-551 Other: Placebo Participants will receive IV placebo matched to inebilizumab.
Experimental: Inebilizumab/Inebilizumab AQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.	Drug: Inebilizumab Participants will receive IV inebilizumab 300 mg. Other Name: MEDI-551 Other: Placebo Participants will receive IV placebo matched to inebilizumab.

Arms

Assigned Interventions

Placebo Comparator: Placebo/Inebilizumab
Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.

Drug: Inebilizumab
Participants will receive IV inebilizumab 300 mg.

Other Name: MEDI-551

Other: Placebo
Participants will receive IV placebo matched to inebilizumab.

Experimental: Inebilizumab/Inebilizumab
AQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.

Drug: Inebilizumab
Participants will receive IV inebilizumab 300 mg.

Other Name: MEDI-551

Other: Placebo
Participants will receive IV placebo matched to inebilizumab.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo/Inebilizumab	Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Description

Placebo/Inebilizumab

Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Inebilizumab/Inebilizumab

AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Participant Flow for 2 periods

Period 1: Randomized-controlled Period (RCP)

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
STARTED	56	175
Treated	56	174
COMPLETED	54	169
NOT COMPLETED	2	6
Adverse Event	0	2
Withdrawal by Subject	1	1
Participants randomized, but not treated	0	1
Not specified	1	2

Period 2: Open-label Period (OLP)

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
STARTED	51^[1]	165^[2]
COMPLETED	43	131
NOT COMPLETED	8	34
Adverse Event	1	2
Death	1	2
Lost to Follow-up	0	1
Withdrawal by Subject	0	14
Not specified	6	15

[1]	3 participants completed RCP but did not roll over to OLP.
[2]	4 participants completed RCP but did not roll over to OLP.

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The Intent-to-treat (ITT) population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment.

Reporting Groups

	Description
Placebo/Inebilizumab	Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Baseline Measures

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab	Total
Number of Participants [units: Participants]	56	174	230
Age Continuous [units: Years] Mean ± Standard Deviation	42.6 ± 13.9	43.0 ± 11.6	42.9 ± 12.2
Sex: Female, Male [units: Participants]
Female	50	159	209
Male	6	15	21
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	5	14	19
Asian	8	39	47
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	15	20
White	28	92	120
More than one race	0	1	1
Unknown or Not Reported	10	13	23
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	15	28	43
Not Hispanic or Latino	41	146	187
Unknown or Not Reported	0	0	0

Outcome Measures

1. Primary Outcome Measure: Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP [ Time Frame: Day 1 (Baseline) through Day 197 ]

Measure Type	Primary
Measure Name	Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
Measure Description	The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.
Time Frame	Day 1 (Baseline) through Day 197
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment.

Reporting Groups

	Description
Placebo/Inebilizumab	Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	56	174
Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP [units: Days] Median (95% Confidence Interval)	NA (142.0 to NA) ^[1]	NA (NA to NA) ^[1]

Statistical Analysis 1 for Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	<0.0001
Hazard Ratio (HR)^[5]	0.272
95% Confidence Interval	( 0.1496 to 0.4961 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP [ Time Frame: Day 1 (Baseline) through Day 197 ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP
Measure Description	EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Time Frame	Day 1 (Baseline) through Day 197
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment.

Reporting Groups

	Description
Placebo/Inebilizumab	Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	56	174
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP [units: Percentage of Participants]	33.9	14.9

Statistical Analysis 1 for Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP

Groups^[1]	All groups
Method^[3]	Regression, Logistic
P-Value^[4]	0.0033
Odds Ratio (OR)^[5]	0.352
95% Confidence Interval	( 0.1755 to 0.7059 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

3. Secondary Outcome Measure: Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP [ Time Frame: Day 1 (Baseline) through Day 197 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP
Measure Description	Low-contrast visual acuity test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision.
Time Frame	Day 1 (Baseline) through Day 197
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. Participants with low contrast visual acuity binocular score were analyzed for this outcome measure.

Reporting Groups

	Description
Placebo/Inebilizumab	Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	56	171
Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP [units: Score on scale] Least Squares Mean (Standard Error)	1.442 (1.217)	1.576 (0.935)

Statistical Analysis 1 for Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	0.9026
Mean Difference (Net)^[5]	0.134
Standard Error of the mean	± 1.096
95% Confidence Interval	( -2.0254 to 2.2941 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Secondary Outcome Measure: Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP [ Time Frame: From Screening (Day -28) to Day 197 ]

Measure Type	Secondary
Measure Name	Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP
Measure Description	The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.
Time Frame	From Screening (Day -28) to Day 197
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. Participants with observed MRI lesions were analyzed for this outcome measure.

Reporting Groups

	Description
Placebo/Inebilizumab	Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	32	79
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP [units: Number of lesions] Mean (Standard Deviation)	2.3 (1.3)	1.6 (1.0)

Statistical Analysis 1 for Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP

Groups^[1]	All groups
Method^[3]	Other [Negative Binomial Regression]
P-Value^[4]	0.0034
Other^[5]	0.566
95% Confidence Interval	( 0.3866 to 0.8279 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: Number of NMOSD-related in-patient Hospitalizations During RCP [ Time Frame: Day 1 (Baseline) through Day 197 ]

Measure Type	Secondary
Measure Name	Number of NMOSD-related in-patient Hospitalizations During RCP
Measure Description	Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission.
Time Frame	Day 1 (Baseline) through Day 197
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. Participants with in-patient hospitalization were analyzed for this outcome measure.

Reporting Groups

	Description
Placebo/Inebilizumab	Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	8	11
Number of NMOSD-related in-patient Hospitalizations During RCP [units: Number of In-patient Hospitalizations] Mean (Standard Deviation)	1.4 (0.7)	1.0 (0)

Statistical Analysis 1 for Number of NMOSD-related in-patient Hospitalizations During RCP

Groups^[1]	All groups
Method^[3]	Other [Negative Binomial Regression]
P-Value^[4]	0.0146
Other^[5]	0.317
95% Confidence Interval	( 0.1257 to 0.7972 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

6. Secondary Outcome Measure: Annualized AC-determined NMOSD Attack Rate During any Exposure to Inebilizumab [ Time Frame: For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years) ]

Measure Type	Secondary
Measure Name	Annualized AC-determined NMOSD Attack Rate During any Exposure to Inebilizumab
Measure Description	Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported.
Time Frame	For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Any inebilizumab population included all participants who received at least one dose of inebilizumab either in the RCP or OLP.

Reporting Groups

	Description
Any Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 in RCP or IV inebilizumab 300 mg on both Day 1 and Day 15 in OLP ; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.

Measured Values

	Any Inebilizumab
Number of Participants Analyzed [units:participants]	225
Annualized AC-determined NMOSD Attack Rate During any Exposure to Inebilizumab [units: Annualized attack rate]	0.086

No statistical analysis provided for Annualized AC-determined NMOSD Attack Rate During any Exposure to Inebilizumab

7. Secondary Outcome Measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP [ Time Frame: Day 1 (Baseline) through Day 197 ]

Measure Type	Secondary
Measure Name	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP
Measure Description	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP.
Time Frame	Day 1 (Baseline) through Day 197
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment received.

Reporting Groups

	Description
Placebo/Inebilizumab	Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who entered OLP received IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.
Inebilizumab/Inebilizumab	AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants had choice to enter in the SFP at any point during RCP or OLP and were free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants continued in the SFP for 12 months from last dose of study drug.

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	56	174
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP [units: Participants]
TEAEs	41	127
TESAEs	6	9

No statistical analysis provided for Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP

8. Secondary Outcome Measure: Number of Participants With TEAEs and TESAEs During OLP [ Time Frame: Day 198 through end of OLP period (maximum of 3 years after the last participant entered, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) ]

Measure Type	Secondary
Measure Name	Number of Participants With TEAEs and TESAEs During OLP
Measure Description	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP.
Time Frame	Day 198 through end of OLP period (maximum of 3 years after the last participant entered, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Open-label population included all participants who received at least one dose of inebilizumab during OLP.

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	51	165
Number of Participants With TEAEs and TESAEs During OLP [units: Participants]
TEAEs	45	144
TESAEs	19	22

No statistical analysis provided for Number of Participants With TEAEs and TESAEs During OLP

9. Secondary Outcome Measure: Number of Participants With TEAEs and TESAEs During SFP (Open-label Population) [ Time Frame: Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years) ]

Measure Type	Secondary
Measure Name	Number of Participants With TEAEs and TESAEs During SFP (Open-label Population)
Measure Description	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. Participant who prematurely discontinued from the RCP or OLP entered in the SFP.
Time Frame	Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Open-label population included all participants who received at least one dose of inebilizumab during OLP.

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	51	165
Number of Participants With TEAEs and TESAEs During SFP (Open-label Population) [units: Participants]
TEAEs	3	5
TESAEs	2	1

No statistical analysis provided for Number of Participants With TEAEs and TESAEs During SFP (Open-label Population)

10. Secondary Outcome Measure: Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population) [ Time Frame: Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years) ]

Measure Type	Secondary
Measure Name	Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population)
Measure Description	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. The SFP started when a participant prematurely discontinues from the RCP or OLP.
Time Frame	Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Non-OLP population included all participants who received any dose of study drug, analyzed according to the treatment received in RCP, but did not roll over to OLP.

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	5	9
Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population) [units: Participants]
TEAEs	2	3
TESAEs	1	1

No statistical analysis provided for Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population)

11. Secondary Outcome Measure: Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP [ Time Frame: Day 1 (Baseline) through Day 197 ]

Measure Type	Secondary
Measure Name	Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP
Measure Description	Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported.
Time Frame	Day 1 (Baseline) through Day 197
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment received. 'Number of Participants analyzed' signifies participants who were analyzed for this outcome measure.

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	56	173
Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP [units: Participants]
Hemoglobin (decreased)	0	2
Leukocytes (decreased)	1	11
Lymphocytes (decreased)	5	35
Lymphocytes (increased)	4	1
Neutrophils (decreased)	0	10
Alanine Aminotransferase (increased)	1	4
Aspartate Aminotransferase (increased)	2	1
Bilirubin (increased)	2	1
Cholesterol (increased)	2	5
Creatinine (increased)	1	5
Gamma glutamyl transferase (increased)	1	6
Glucose (decreased)	1	1
Glucose (increased)	5	1
Potassium (decreased)	0	1
Sodium (decreased)	1	2
Triglycerides (increased)	2	7

No statistical analysis provided for Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP

12. Secondary Outcome Measure: Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP [ Time Frame: Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) ]

Measure Type	Secondary
Measure Name	Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP
Measure Description	Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported.
Time Frame	Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Open-label population included all participants who received at least one dose of study drug during OLP.

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	51	165
Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP [units: Participants]
Hemoglobin (decreased)	2	6
Leukocytes (decreased)	1	12
Lymphocytes (decreased)	9	21
Lymphocytes (increased)	1	4
Neutrophils (decreased)	1	16
Alanine aminotransferase (increased)	4	2
Albumin (decreased)	0	3
Alkaline phosphatase (increased)	1	1
Aspartate aminotransferase (increased)	2	3
Cholesterol (increased)	1	5
Creatinine (increased)	3	7
Gamma glutamyl transferase (increased)	1	10
Glucose (decreased)	0	3
Glucose (increased)	5	5
Potassium (decreased)	0	1
Potassium (increased)	1	2
Sodium (decreased)	2	1
Triglycerides (increased)	4	6
Urate (increased)	1	1
Hemoglobin (increased)	0	1
Bilirubin	2	0

No statistical analysis provided for Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP

13. Secondary Outcome Measure: Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP) [ Time Frame: Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) ]

Measure Type	Secondary
Measure Name	Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP)
Measure Description	Time to maximum serum concentration of inebilizumab during RCP is reported.
Time Frame	Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. 'Number analyzed' signifies participants who had adequate pharmacokinetic sample of inebilizumab per the specified dose levels (Dose 1 and Dose 2).

Reporting Groups

Description

Inebilizumab/Inebilizumab

Measured Values

	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	173
Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP) [units: Days] Median (Full Range)
Dose 1	0.07 (0.07 to 7.00)
Dose 2	0.07 (0.07 to 14.00)

No statistical analysis provided for Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP)

14. Secondary Outcome Measure: Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP) [ Time Frame: Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) ]

Measure Type	Secondary
Measure Name	Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP)
Measure Description	Maximum observed serum concentration of inebilizumab during RCP is reported.
Time Frame	Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. 'Number analyzed' signifies participants who had adequate pharmacokinetic sample of inebilizumab per the specified dose levels (Dose 1 and Dose 2).

Reporting Groups

Description

Inebilizumab/Inebilizumab

Measured Values

	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	173
Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP) [units: μg/mL] Geometric Mean (Geometric Coefficient of Variation)
Dose 1	97.7 (37.4%)
Dose 2	108 (45.4%)

No statistical analysis provided for Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP)

15. Secondary Outcome Measure: Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP) [ Time Frame: Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197) ]

Measure Type	Secondary
Measure Name	Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP)
Measure Description	Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported.
Time Frame	Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. 'Number analyzed' signifies participants who had adequate pharmacokinetic sample of inebilizumab per the specified dose levels (Dose 1 and Dose 2).

Reporting Groups

Description

Inebilizumab/Inebilizumab

Measured Values

	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	167
Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP) [units: μg*d/mL] Geometric Mean (Geometric Coefficient of Variation)
Dose 1	667 (31.3%)
Dose 2	967 (39.6%)

No statistical analysis provided for Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP)

16. Secondary Outcome Measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP) [ Time Frame: Pre and post dose on Day 1; and on Days 29, 85, and 197 ]

Measure Type	Secondary
Measure Name	Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP)
Measure Description	Number of participants with positive ADA titer to inebilizumab during RCP is reported.
Time Frame	Pre and post dose on Day 1; and on Days 29, 85, and 197
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all participants who were randomized, received any study drug, and grouped according to their randomized treatment. 'Number analyzed' signifies the number of participants who had adequate ADA samples.

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	56	174
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP) [units: Participants]
ADA positive at anytime including baseline (BL)	8	17
ADA positive at BL; not detected post-BL	0	5
ADA positive post-BL; positive at BL	4	7
ADA positive post-BL; not detected at BL	4	5

No statistical analysis provided for Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP)

17. Secondary Outcome Measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP) [ Time Frame: Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years) ]

Measure Type	Secondary
Measure Name	Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP)
Measure Description	Number of participants with positive ADA titer to inebilizumab in OLP is reported.
Time Frame	Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Open-label population included all participants who received at least one dose of inebilizumab during OLP. 'Number analyzed' signifies the number of participants who had adequate ADA samples.

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Measured Values

	Placebo/Inebilizumab	Inebilizumab/Inebilizumab
Number of Participants Analyzed [units:participants]	51	165
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP) [units: Participants]
ADA positive at any time including baseline (BL)	9	22
ADA positive at BL; not detected post-BL	0	5
ADA positive post-BL and positive at BL	4	7
ADA positive post-BL; not detected at BL	5	10

No statistical analysis provided for Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP)

Serious Adverse Events

Time Frame	From Day 1 through the end of study (approximately 5 years 10 months)
Additional Description	Adverse events are reported for all 3 study periods combined (RCP, OLP, and SFP).

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Serious Adverse Events

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Total, serious adverse events

# participants affected / at risk

24/56 (42.86%)

28/174 (16.09%)

Hepatobiliary disorders

Hepatic failure¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Hepatobiliary disorders

Hepatic function abnormal¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Covid-19 pneumonia¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Renal abscess¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Investigations

International normalised ratio increased¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Investigations

Weight decreased¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

1/56 (1.79%)

1/174 (0.57%)

# events

Nervous system disorders

Optic neuritis¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Nervous system disorders

Peripheral nerve palsy¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Renal and urinary disorders

Calculus bladder¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Blood and lymphatic system disorders

Neutropenia¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Ear and labyrinth disorders

Deafness¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Endocrine disorders

Adrenal insufficiency¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Endocrine disorders

Steroid withdrawal syndrome¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Eye disorders

Blindness unilateral¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Eye disorders

Cataract¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Eye disorders

Vision blurred¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Eye disorders

Visual acuity reduced¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain upper¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Gastrointestinal disorders

Ileus¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Gastrointestinal disorders

Umbilical hernia¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

General disorders and administration site conditions

Chest pain¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

1/56 (1.79%)

1/174 (0.57%)

# events

Hepatobiliary disorders

Cholangitis acute¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Hepatobiliary disorders

Cholecystitis acute¹,^†

# participants affected / at risk

1/56 (1.79%)

1/174 (0.57%)

# events

Infections and infestations

Appendicitis¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Appendicitis perforated¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Atypical pneumonia¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Bacteraemia¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Bronchiolitis¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Covid-19¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Central nervous system infection¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Chorioretinitis¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Hepatitis a¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Herpes zoster¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Intervertebral discitis¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Meningitis viral¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Neuroborreliosis¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Osteomyelitis¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

3/56 (5.36%)

3/174 (1.72%)

# events

Infections and infestations

Pneumonia bacterial¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Progressive multifocal leukoencephalopat¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Infections and infestations

Pyelonephritis chronic¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Sepsis¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Septic shock¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Sinusitis¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Subcutaneous abscess¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

7/56 (12.50%)

3/174 (1.72%)

# events

Injury, poisoning and procedural complications

Burns third degree¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Injury, poisoning and procedural complications

Foot fracture¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Injury, poisoning and procedural complications

Infusion related reaction¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Injury, poisoning and procedural complications

Overdose¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Injury, poisoning and procedural complications

Wrist fracture¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Metabolism and nutrition disorders

Hyponatraemia¹,^†

# participants affected / at risk

2/56 (3.57%)

0/174 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

0/56 (0.00%)

2/174 (1.15%)

# events

Musculoskeletal and connective tissue disorders

Arthritis¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Musculoskeletal and connective tissue disorders

Connective tissue disorder¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Musculoskeletal and connective tissue disorders

Muscular weakness¹,^†

# participants affected / at risk

2/56 (3.57%)

0/174 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Musculoskeletal and connective tissue disorders

Rhabdomyolysis¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer female¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Nervous system disorders

Cerebrovascular accident¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Nervous system disorders

Lumbosacral radiculopathy¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Nervous system disorders

Migraine¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Nervous system disorders

Myelitis transverse¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Nervous system disorders

Neuromyelitis optica spectrum disorder¹,^†

# participants affected / at risk

2/56 (3.57%)

3/174 (1.72%)

# events

Nervous system disorders

Post cardiac arrest syndrome¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

Nervous system disorders

Seizure¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Nervous system disorders

Unresponsive to stimuli¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Nervous system disorders

Uraemic encephalopathy¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Psychiatric disorders

Delirium¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

2/56 (3.57%)

0/174 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pickwickian syndrome¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory failure¹,^†

# participants affected / at risk

1/56 (1.79%)

1/174 (0.57%)

# events

Respiratory, thoracic and mediastinal disorders

Sleep apnoea syndrome¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Skin and subcutaneous tissue disorders

Drug reaction with eosinophilia and syst¹,^†

# participants affected / at risk

1/56 (1.79%)

0/174 (0.00%)

# events

Vascular disorders

Shock¹,^†

# participants affected / at risk

0/56 (0.00%)

1/174 (0.57%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 23.1

Other Adverse Events

Time Frame	From Day 1 through the end of study (approximately 5 years 10 months)
Additional Description	Adverse events are reported for all 3 study periods combined (RCP, OLP, and SFP).

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

Description

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Other Adverse Events

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Total, other (not including serious) adverse events

# participants affected / at risk

48/56 (85.71%)

138/174 (79.31%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

4/56 (7.14%)

11/174 (6.32%)

# events

Eye disorders

Dry eye¹,^†

# participants affected / at risk

6/56 (10.71%)

4/174 (2.30%)

# events

Eye disorders

Eye pain¹,^†

# participants affected / at risk

5/56 (8.93%)

8/174 (4.60%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

4/56 (7.14%)

3/174 (1.72%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

7/56 (12.50%)

9/174 (5.17%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

8/56 (14.29%)

15/174 (8.62%)

# events

Gastrointestinal disorders

Gastritis¹,^†

# participants affected / at risk

3/56 (5.36%)

3/174 (1.72%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

9/56 (16.07%)

15/174 (8.62%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

6/56 (10.71%)

9/174 (5.17%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

3/56 (5.36%)

12/174 (6.90%)

# events

General disorders and administration site conditions

Influenza like illness¹,^†

# participants affected / at risk

4/56 (7.14%)

3/174 (1.72%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

5/56 (8.93%)

9/174 (5.17%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

5/56 (8.93%)

12/174 (6.90%)

# events

Infections and infestations

Conjunctivitis¹,^†

# participants affected / at risk

3/56 (5.36%)

5/174 (2.87%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

4/56 (7.14%)

17/174 (9.77%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

11/56 (19.64%)

38/174 (21.84%)

# events

Infections and infestations

Oral herpes¹,^†

# participants affected / at risk

4/56 (7.14%)

5/174 (2.87%)

# events

Infections and infestations

Rhinitis¹,^†

# participants affected / at risk

2/56 (3.57%)

9/174 (5.17%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

10/56 (17.86%)

28/174 (16.09%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

20/56 (35.71%)

40/174 (22.99%)

# events

Injury, poisoning and procedural complications

Fall¹,^†

# participants affected / at risk

3/56 (5.36%)

11/174 (6.32%)

# events

Injury, poisoning and procedural complications

Infusion related reaction¹,^†

# participants affected / at risk

9/56 (16.07%)

22/174 (12.64%)

# events

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

4/56 (7.14%)

1/174 (0.57%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

12/56 (21.43%)

28/174 (16.09%)

# events

Musculoskeletal and connective tissue disorders

Muscle spasms¹,^†

# participants affected / at risk

4/56 (7.14%)

5/174 (2.87%)

# events

Musculoskeletal and connective tissue disorders

Muscular weakness¹,^†

# participants affected / at risk

4/56 (7.14%)

4/174 (2.30%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

3/56 (5.36%)

5/174 (2.87%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

9/56 (16.07%)

11/174 (6.32%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

3/56 (5.36%)

7/174 (4.02%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

13/56 (23.21%)

31/174 (17.82%)

# events

Nervous system disorders

Hypoaesthesia¹,^†

# participants affected / at risk

2/56 (3.57%)

12/174 (6.90%)

# events

Nervous system disorders

Paraesthesia¹,^†

# participants affected / at risk

2/56 (3.57%)

12/174 (6.90%)

# events

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

6/56 (10.71%)

8/174 (4.60%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

6/56 (10.71%)

10/174 (5.75%)

# events

Renal and urinary disorders

Micturition urgency¹,^†

# participants affected / at risk

3/56 (5.36%)

2/174 (1.15%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

6/56 (10.71%)

17/174 (9.77%)

# events

Skin and subcutaneous tissue disorders

Alopecia¹,^†

# participants affected / at risk

3/56 (5.36%)

5/174 (2.87%)

# events

Skin and subcutaneous tissue disorders

Eczema¹,^†

# participants affected / at risk

4/56 (7.14%)

4/174 (2.30%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

6/56 (10.71%)

7/174 (4.02%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

4/56 (7.14%)

7/174 (4.02%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

3/56 (5.36%)

5/174 (2.87%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

4/56 (7.14%)

2/174 (1.15%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

8/56 (14.29%)

24/174 (13.79%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea¹,^†

# participants affected / at risk

3/56 (5.36%)

3/174 (1.72%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 23.1

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Viela Bio has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it is understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multicentre publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

In the safety follow-up period (SFP), only 1 participant from ‘Placebo/Inebilizumab’ arm rolled over to SFP and no participant from ‘Inebilizumab /Inebilizumab’ arm rolled over to SFP. For EudraCT result posting, a study period with any one of the arm with zero participants started is not acceptable (EudraCT limitation). Therefore, not included SFP in ‘Participant Flow’ section to keep the data consistent across registry portals.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca Clinical study Information Center
Phone	+1-877-240-9479
E-mail:	[email protected]

Documents available

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Download
CD-IA-MEDI-551-1155 Redacted Protocol
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

MedImmune, LLC MedImmune, LLC

MedImmune, LLC

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

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CD-IA-MEDI-551-1155 Redacted Protocol

Trial Results Summaries

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CD-IA-MEDI-551-1155&attachmentIdentifier=ae7e7dac-afeb-4a4e-bf68-5ce2e36292b8&fileName=statistical_analysis_plan_cd-ia-medi-551-1155_amendment_4-redacted_PDFA.pdf&versionIdentifier=