Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

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

Treatment groups

105 Participants
are divided into 3 treatment groups