Status:
RECRUITING
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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).
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2027
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT06015737
Start Date
June 29 2024
End Date
August 20 2027
Last Update
March 11 2026
Active Locations (272)
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1
Research Site
Glendale, Arizona, United States, 85306
2
Research Site
Phoenix, Arizona, United States, 85028
3
Research Site
Covina, California, United States, 91722
4
Research Site
Fountain Valley, California, United States, 92708