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.
Status: Recruiting
Location: See all (273) locations...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
‣ CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
⁃ CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 at Screening and confirmed at randomization.
⁃ Inadequate response or intolerant to antimalarial therapy.
• Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
• Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
Locations
United States
Arizona
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Glendale
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Phoenix
California
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Covina
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Fountain Valley
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La Jolla
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Los Angeles
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Los Angeles
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Orange
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Orange
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San Francisco
Colorado
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Aurora
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Denver
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New Haven
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Washington D.c.
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Miami
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Miami
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Plantation
Illinois
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Chicago
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Chicago
Indiana
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Indianapolis
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Murray
Massachusetts
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Boston
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Baltimore
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Ann Arbor
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Ann Arbor
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Rochester
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Omaha
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Midland Park
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Portland
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Providence
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Charleston
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Rosario
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Khlong Luang
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Khon Kaen
Turkey
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Istanbul
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Istanbul
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Karşıyaka
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Kayseri
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United Kingdom
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London
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London
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London
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Newcastle Upon Tyne
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-06-29
Estimated Completion Date: 2027-12-29
Participants
Target number of participants: 460
Treatments
Experimental: Stage 1: Anifrolumab
The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.
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.
Experimental: Stage 2: Anifrolumab
The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.
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.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Parexel