Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) … (NCT07440537) | Clinical Trial Compass
RecruitingPhase 2
Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
China105 participantsStarted 2026-04-27
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).
Who can participate
Age range
18 Years – 75 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
. Aged ≥18 and ≤75 years.
. Diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit.
. CLASI activity (CLASI-A) score ≥8 at both the screening and baseline (Day 1) visits.
. May have concomitant systemic lupus erythematosus (SLE) or not.
. The treatment regimen is stable and can be maintained until the end of the study treatment.
. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the first dose on Day 1.
. Women of childbearing potential (WOCBP) and male subjects must agree to use highly effective contraceptive methods throughout the study treatment period and for one month (28 days) after the last dose
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16.
Timeframe: All the subjects completed the 16-week assessment.
. Subjects with active kidney disease 4．Other inflammatory joint or skin diseases or overlap syndrome not caused by systemic lupus erythematosus (SLE) as the primary disease.
.Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.