A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

Eligibility 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.
• * CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 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.
• * Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
• * 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 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.