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NCT06015737

A Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

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
AstraZeneca·Phase 3·ClinicalTrials.gov·combination productNot yet recruiting
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Study focus
Disease/Condition
Cutaneous Lupus Erythematosus
Drug/Device/Intervention
Anifrolumab
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
AstraZeneca
Timeline & enrollment
Phase
Phase 3
Start date
Oct 25, 2023
End date
Dec 16, 2026
Enrollment
230 participants
Primary outcome

Number of participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) CLASI-A Responder Index-7 (CRI- 7) response (United States),Number of participants with CLASI-70 response (European Union and Rest of the World)

Summary

This study aims to evaluate the efficacy and safety of a subcutaneous (SC) treatment regimen
 of dose A of anifrolumab versus placebo in adult participants with cutaneous lupus
 erythematosus (CLE).

ICD-10 classifications
Subacute cutaneous lupus erythematosusLupus erythematosusDiscoid lupus erythematosusSystemic lupus erythematosusSystemic lupus erythematosus, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06015737
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06015737 through Pure Global AI's free database. This Phase 3 trial is sponsored by AstraZeneca and is currently Not yet recruiting. The study focuses on Cutaneous Lupus Erythematosus. Target enrollment is 230 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.