A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutane… (NCT06980805) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
United States, Argentina, Bulgaria56 participantsStarted 2025-02-19
Plain-language summary
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.
The study will consist of 3 periods:
Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks.
Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks.
Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.
Who can participate
Age range
18 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.
Inclusion Criteria:
* Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.
* Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with a CLASI-A score of ≥8 and \<10 are eligible if the score does not include alopecia and/or mucous membrane lesions.
* Have active CLE despite an adequate trial of conventional therapies.
* Are positive for at least one autoantibody at Screening.
Exclusion Criteria:
* Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE.
* Have rapidly progressive nephritis.
* Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
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.
1Since this trial is in Phase 2 and is no longer recruiting, what does that mean for my chances of getting access to IMVT-1402, and are there other ways I might be able to access it if the results look promising?
2The trial measures improvement in skin disease activity using something called the CLASI-A score at 12 weeks — is that enough time to know whether a treatment is truly working for someone with my type of cutaneous lupus, whether subacute or chronic?
3IMVT-1402 appears to target a pathway related to antibody levels in the body — given my specific health history, would lowering those antibody levels raise any safety concerns my doctor would want to monitor closely?
4Before considering a trial like this one, should I try any of the currently approved or standard treatments for cutaneous lupus first, and how would that affect my eligibility if future opportunities with this drug come up?
5Since the trial is actively running but no longer enrolling, could my doctor find out what the early safety and tolerability results look like so far, and would that information change the treatment path they'd recommend for me right now?
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
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12