Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) … (NCT07440537) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
China105 participantsStarted 2026-03
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 range18 Years – 75 Years
SexALL
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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
✕. 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.
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.
✕.Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.