A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
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 Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy.
AstraZeneca
302 participants
Jun 29, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Matching placebo solution for injection in aPFS.
Locations(272)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06015737