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NCT06015737 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
A Phase 3 study of Cutaneous Lupus Erythematosus, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 302
- Enrollment target
- 20
- Study locations
NCT06015737: Recruiting Phase 3 study of Cutaneous Lupus Erythematosus, sponsored by AstraZeneca.
NCT06015737 is a Phase 3 study of Cutaneous Lupus Erythematosus that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 302 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06015737, a Phase 3 study of Cutaneous Lupus Erythematosus, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 302 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).
Primary Outcome
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. It consists of 2 separate scores: i) activity of the disease, and ii) measure of damage. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. CLASI-70 responder (Yes/No) is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.
Conditions Studied
Interventions
- OTHER Placebo
- COMBINATION_PRODUCT Anifrolumab
Study Locations (20)
California
- Research Site - Covina
- Research Site - Fountain Valley
- Research Site - La Jolla
- Research Site - Los Angeles
- Research Site - Los Angeles
- Research Site - Orange
- Research Site - Orange
- Research Site - San Francisco
Florida
- Research Site - Fort Lauderdale
- Research Site - Miami
- Research Site - Miami
- Research Site - Plantation
Arizona
- Research Site - Glendale
- Research Site - Phoenix
Colorado
- Research Site - Aurora
- Research Site - Denver
Illinois
- Research Site - Chicago
- Research Site - Chicago
Connecticut
- Research Site - New Haven
District of Columbia
- Research Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2024-06-29 |
| Est. Completion | 2027-08-20 |
| Phase | Phase 3 |
What NCT06015737 shows while recruiting
NCT06015737 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Cutaneous Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06015737 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06015737 about?
NCT06015737 is a clinical study titled "A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus". This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).
What is the current status of trial NCT06015737?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2024-06-29. Estimated completion is 2027-08-20.
What conditions does trial NCT06015737 study?
This clinical trial studies the following conditions: Cutaneous Lupus Erythematosus.
What interventions are being tested in trial NCT06015737?
The interventions under investigation include: Placebo (OTHER), Anifrolumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06015737?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06015737 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06015737's enrollment target sits among peer trials
302 1120th of 2000 higher than 880 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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