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Clinical Trials in China / NCT06015737
Active, not recruiting Phase 3

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

NCT06015737 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-06-29
Last updated
2026-07-29

Condition(s) studied

Cutaneous Lupus Erythematosus

Investigational drug(s) / intervention(s)

AnifrolumabPlacebo

Anifrolumab: Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).

Placebo: Matching placebo solution for injection in aPFS.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Key inclusion criteria: * 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. * 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. Key exclusion criteria: * History or evidence of suicidal ideation. * Severe or life-threatening Systemic lupus erythematosus (SLE). * Active SLE or Sjögren's Syndrome. * Any active skin conditions other than CLE that may interfere with the study. * History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS). * History of recurrent infection requiring hospitalization and IV antibiotics. * COVID-19 infection. * Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies. * At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcome measure(s)

Trial sites (188)

FacilityCityRegionStatus
Research Site Phoenix Arizona
Research Site Covina California
Research Site La Jolla California
Research Site Los Angeles California
Research Site Los Angeles California
Research Site Orange California
Research Site San Francisco California
Research Site Aurora Colorado
Research Site New Haven Connecticut
Research Site Washington D.C. District of Columbia
Research Site Fort Lauderdale Florida
Research Site Miami Florida
Research Site Plantation Florida
Research Site Chicago Illinois
Research Site Chicago Illinois
Research Site Indianapolis Indiana
Research Site Baltimore Maryland
Research Site Boston Massachusetts
Research Site Boston Massachusetts
Research Site Ann Arbor Michigan
Research Site Bloomfield Hills Michigan
Research Site Rochester Minnesota
Research Site Omaha Nebraska
Research Site New York New York
Research Site Rochester New York
Research Site Charlotte North Carolina
Research Site Statesville North Carolina
Research Site Cleveland Ohio
Research Site Portland Oregon
Research Site Providence Rhode Island
Research Site Charleston South Carolina
Research Site Dallas Texas
Research Site Charlottesville Virginia
Research Site Roanoke Virginia
Research Site Ciudad de Buenos Aires Argentina
Research Site Córdoba Argentina
Research Site Córdoba Argentina
Research Site Quilmes Argentina
Research Site San Miguel Argentina
Research Site Kogarah Australia

+ 148 more sites — see the full list on the official registry below.

On this site

📄 Saphnelo (anifrolumab) drug profile →

More AstraZeneca trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06015737 on ClinicalTrials.gov ↗ ← All trials in China