A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic an… (NCT06015737) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
United States, Argentina, Australia339 participantsStarted 2024-06-29
Plain-language 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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for chronic and/or subacute cutaneous lupus — does my particular type and severity of cutaneous lupus match what this study is looking for, and is it worth discussing with you whether I might fit the eligibility criteria?
2The trial measures success as a 70% reduction in a skin activity score called CLASI-A — can you explain what that score means for my current symptoms, and what it would realistically look like if my skin disease improved by that amount?
3Since this is a Phase 3 trial, anifrolumab has already been tested in earlier phases, including in systemic lupus — what does the existing safety data suggest about risks I should be aware of before considering this drug?
4The study is no longer actively recruiting, so enrollment is closed — are there other ongoing trials or recently approved options for cutaneous lupus that we should be looking at instead?
5If I can't join this trial, would standard treatments for my type of cutaneous lupus be a reasonable path right now, and how do those options compare to what anifrolumab is being tested for here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score