NCT07440537

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cutaneous Lupus Erythematosus (CLE)

Interventions

Type	Name	Description
DRUG	ICP-488 Tablets	Patients will receive ICP-488 orally as per the protocol
DRUG	ICP-488 Tablets	Patients will receive ICP-488 orally as per the protocol
OTHER	ICP-488 Placebo	Patients will receive ICP-488 Placebo orally as per the protocol.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

26 sites across 1 country: China