A 2-stage, Phase III study to investigate the efficacy and safety of anifrolumab in adults with chronic and/or subacute cutaneous lupus erythematosus - LAVENDER
Study identifier:D346BC00001
ClinicalTrials.gov identifier:NCT06015737
EudraCT identifier:2021-003698-70
CTIS identifier:2023-503692-24-00
Recruiting
Official Title
A Multicenter, Randomized, Double blind, Placebo controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy
Medical condition
Cutaneous lupus erythematosus
Phase
Phase 3
Healthy volunteers
No
Study drug
Anifrolumab
Sex
All
Estimated Enrollment
460
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 29 Jun 2024
Estimated Primary Completion Date: 29 Dec 2027
Estimated Study Completion Date: 29 Dec 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
PAREXEL
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Stage 1: Anifrolumab The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51. | Combination Product: Anifrolumab Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS). |
| Placebo Comparator: Stage 1: Placebo The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51. | Other: Placebo Matching placebo solution for injection in aPFS. |
| Experimental: Stage 2: Anifrolumab The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51. | Combination Product: Anifrolumab Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS). |
| Placebo Comparator: Stage 2: Placebo The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51. | Other: Placebo Matching placebo solution for injection in aPFS. |
