Anifrolumab: Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Placebo: Matching placebo solution for injection in aPFS.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score — At Week 24 The CLASI is a validated index used for assessing the cutaneous lesions of SLE. It consists of 2 separate scores: i) activity of the disease, and ii) measure of damage. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. CLASI-70 responder (Yes/No) is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.
Trial sites (188)
Facility
City
Region
Status
Research Site
Phoenix
Arizona
Research Site
Covina
California
Research Site
La Jolla
California
Research Site
Los Angeles
California
Research Site
Los Angeles
California
Research Site
Orange
California
Research Site
San Francisco
California
Research Site
Aurora
Colorado
Research Site
New Haven
Connecticut
Research Site
Washington D.C.
District of Columbia
Research Site
Fort Lauderdale
Florida
Research Site
Miami
Florida
Research Site
Plantation
Florida
Research Site
Chicago
Illinois
Research Site
Chicago
Illinois
Research Site
Indianapolis
Indiana
Research Site
Baltimore
Maryland
Research Site
Boston
Massachusetts
Research Site
Boston
Massachusetts
Research Site
Ann Arbor
Michigan
Research Site
Bloomfield Hills
Michigan
Research Site
Rochester
Minnesota
Research Site
Omaha
Nebraska
Research Site
New York
New York
Research Site
Rochester
New York
Research Site
Charlotte
North Carolina
Research Site
Statesville
North Carolina
Research Site
Cleveland
Ohio
Research Site
Portland
Oregon
Research Site
Providence
Rhode Island
Research Site
Charleston
South Carolina
Research Site
Dallas
Texas
Research Site
Charlottesville
Virginia
Research Site
Roanoke
Virginia
Research Site
Ciudad de Buenos Aires
Argentina
Research Site
Córdoba
Argentina
Research Site
Córdoba
Argentina
Research Site
Quilmes
Argentina
Research Site
San Miguel
Argentina
Research Site
Kogarah
Australia
+ 148 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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