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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Cutaneous Lupus Erythematosus (CLE)

In brief

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).

Key facts

Study ID

NCT07440537

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

105

Starts

2026-04-27

Expected to finish

2027-12-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Other autoimmune diseases except for secondary Sjögren's syndrome. 6. Concurrent herpes zoster infection at screening or before dosing on Day 1, or a history of severe herpes zoster or severe herpes simplex infection.
• Positive Hepatitis B surface Antigen (HBsAg) at screening; or abnormal Hepatitis B Virus (HBV)Deoxyribonucleic Acid (DNA) Polymerase Chain Reaction (PCR) test result in subjects positive for Hepatitis B core Antibody (HBcAb).
• 8 Evidence of active, latent, or inadequately treated mycobacterium tuberculosis (TB) infection.
• Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.
• Inadequate organ function levels, including abnormalities in hematology, liver function, renal function, coagulation function, cardiac function, etc.

Where it is running

• Jinan Central Hospital — Jinan, Shandong, China (enrolling)
• Dermatology Hospital of Shandong First Medical University — Jinan, Shandong, China (enrolling)
• Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• Dermatology Hospital of Jiangxi Province — Nanchang, Jiangxi, China (enrolling)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
• Dongguan people's hospital — Dongguan, Guangdong, China (enrolling)
• The First AffiliatedHospital of China Medical University — Shenyang, Liaoning, China
• Shanghai Skin Disease Hospital — Shanghai, Shanghai Municipality, China
• First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
• People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang Uygur Autonomous Region, China
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
• Hangzhou Third people's Hospital — Hangzhou, Zhejiang, China
• Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• Chongqing Hospital of Traditional Chinese Medicine — Chongqing, Chongqing Municipality, China
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Jingzhou Central Hospital — Jingzhou, Hubei, China

Full record on ClinicalTrials.gov

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