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A Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus - Trial NCT06015737

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.

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NCT06015737
Phase 3
Not yet recruiting
combination product
Trial Details
ClinicalTrials.gov โ€ข NCT06015737
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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

Study Focus

Anifrolumab

Interventional

combination product

Sponsor & Location

AstraZeneca

Timeline & Enrollment

Phase 3

Oct 25, 2023

Dec 16, 2026

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 erythematosus
Lupus erythematosus
Discoid lupus erythematosus
Systemic lupus erythematosus
Systemic lupus erythematosus, unspecified

Data Source

ClinicalTrials.gov

NCT06015737

Non-Device Trial