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

Key inclusion criteria:

• Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinicallyand 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 andconfirmed at randomization.

• Inadequate response or intolerant to antimalarial therapy.

• Participants should have no medical history or signs or symptoms of active or priortuberculosis infection (TB) and the same should reflect in chest radiograph or achest CT scan result.

• Contraceptive use by males and females should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

• Participants should have a coronavirus disease 2019 (COVID-19) negative PCR orantigen test result as per local policies at Screening.

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 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 onlaboratory test results e.g tests for total bilirubin, serum creatinine etc.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply