About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
Specific cutaneous lupus erythematosus subtypes: acute cutaneous lupus erythematosus (ACLE), tumid lupus, lupus panniculitis (deep lupus), chilblain lupus.
Patients with drug-induced cutaneous lupus erythematosus and/or drug-induced systemic lupus erythematosus.
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.
Trial design
Treatments tested in this trial
- ICP-488 Tablets
- ICP-488 Tablets
- ICP-488 Placebo