A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE)
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).
• Aged ≥18 and ≤75 years.
• Diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit.
• Biopsy-proven histologically consistent with discoid lupus erythematosus (DLE) and/or subacute cutaneous lupus erythematosus (SCLE).
• 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