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)
1 other identifier
interventional
105
1 country
26
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2026
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 27, 2026
February 1, 2026
1 year
February 10, 2026
February 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16.
All the subjects completed the 16-week assessment.
Secondary Outcomes (9)
At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50).
From baseline to week 28
The proportion of subjects with disease improvement as defined by a reduction of ≥4 points relative to the baseline value of CLASI-A （CLASI ≥ 4）at each visit.
From baseline to week 28
The average change of the CLASI-A score from the baseline value at each visit.
From baseline to week 28
The percentage change of CLASI-A relative to the baseline at each visit.
From baseline to week 28
Adverse events that occurred during treatment.
From baseline to week 28
- +4 more secondary outcomes
Study Arms (3)
ICP-488 Dose A
EXPERIMENTALICP-488 Dose B
EXPERIMENTALICP-488 Placebo
PLACEBO COMPARATORInterventions
Patients will receive ICP-488 Placebo orally as per the protocol.
Eligibility Criteria
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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, 400021, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Dongguan people's hospital
Dongguan, Guangdong, 523059, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008, China
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Nanjing, Jiangsu, Qianjin Lu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000, China
The First AffiliatedHospital of China Medical University
Shenyang, Liaoning, 110001, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, 250022, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, 830001, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Hangzhou Third people's Hospital
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 27, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02