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

NCT06015737

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Cutaneous Lupus Erythematosus

Interventions: Anifrolumab, Placebo

Countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (188)

Phoenix, Arizona, United States
Covina, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Bloomfield Hills, Michigan, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
New York, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Statesville, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Providence, Rhode Island, United States
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