Yükleniyor... / Loading...
This study evaluates the efficacy and safety of a drug called Anifrolumab in adults with chronic and/or subacute cutaneous lupus erythematosus (a form of lupus affecting the skin). It enrolled patients with a confirmed diagnosis who had an inadequate response to antimalarial therapy, and participants received either Anifrolumab or placebo. The study is in Phase 3 and is currently active but not recruiting new participants (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
+148
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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