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

Open to people ages 18-70

• 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply