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).

This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in adults with chronic and/or subacute CLE who are refractory and/or intolerant to antimalarial therapy. The study has a randomized, 24-week double-blind, placebo-controlled study period (Week 0 to Week 23), to evaluate the efficacy and safety of anifrolumab. The double-blind study period will be followed by an open-label, uncontrolled treatment period in which all participants will receive treatment with anifrolumab from Week 24 to Week 51. After the open-label treatment period, participants will enter a 12-week Safety Follow-up Period.

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.