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

February 26, 2026 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
      • Beijing, Beijing Municipality, China, 100053
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing Municipality, China, 400021
        • Chongqing Hospital of Traditional Chinese Medicine
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
    • Guangdong
      • Dongguan, Guangdong, China, 523059
      • Guangzhou, Guangdong, China, 510120
      • Guangzhou, Guangdong, China, 510091
        • Dermatology Hospital of Southern Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • The Second Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Jingzhou, Hubei, China, 434020
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Affiliated Drum Tower Hospital, Medical School of Nanjing University
        • Contact:
      • Nanjing, Jiangsu, China, Qianjin Lu
        • Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Dermatology Hospital of Jiangxi Province
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First AffiliatedHospital of China Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250013
      • Jinan, Shandong, China, 250022
        • Dermatology Hospital of Shandong First Medical University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital Fudan University
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • First Hospital of Shanxi Medical University
        • Contact:
          • Shuping Guo
        • Contact:
          • gsp6688@sina.com
    • Sichuan
      • Chengdu, Sichuan, China, 610041
      • Chengdu, Sichuan, China, 610072
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830001
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥18 and ≤75 years.
  2. Diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit.
  3. Biopsy-proven histologically consistent with discoid lupus erythematosus (DLE) and/or subacute cutaneous lupus erythematosus (SCLE).
  4. CLASI activity (CLASI-A) score ≥8 at both the screening and baseline (Day 1) visits.
  5. May have concomitant systemic lupus erythematosus (SLE) or not.
  6. The treatment regimen is stable and can be maintained until the end of the study treatment.
  7. 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.
  8. 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

Exclusion Criteria:

  1. Specific cutaneous lupus erythematosus subtypes: acute cutaneous lupus erythematosus (ACLE), tumid lupus, lupus panniculitis (deep lupus), chilblain lupus.
  2. Patients with drug-induced cutaneous lupus erythematosus and/or drug-induced systemic lupus erythematosus.
  3. 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.

5. 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.

7. 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.

9.Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.

10. Inadequate organ function levels, including abnormalities in hematology, liver function, renal function, coagulation function, cardiac function, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ICP-488 Placebo
Other: ICP-488 Placebo
Patients will receive ICP-488 Placebo orally as per the protocol.
Experimental: ICP-488 Dose A
Drug: ICP-488 Tablets
Patients will receive ICP-488 orally as per the protocol
Experimental: ICP-488 Dose B
Drug: ICP-488 Tablets
Patients will receive ICP-488 orally as per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16.
Time Frame: All the subjects completed the 16-week assessment.
All the subjects completed the 16-week assessment.

Secondary Outcome Measures

Outcome Measure
Time Frame
At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50).
Time Frame: From baseline to week 28
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.
Time Frame: From baseline to week 28
From baseline to week 28
The average change of the CLASI-A score from the baseline value at each visit.
Time Frame: From baseline to week 28
From baseline to week 28
The percentage change of CLASI-A relative to the baseline at each visit.
Time Frame: From baseline to week 28
From baseline to week 28
Adverse events that occurred during treatment.
Time Frame: From baseline to week 28
From baseline to week 28
The incidence of clinical abnormalities such as laboratory test results, electrocardiogram (ECG), and vital signs, and the changes relative to the baseline.
Time Frame: From baseline to week 28
From baseline to week 28
Maximum Concentration at Steady State(Cmax,ss)
Time Frame: From baseline to week 12
From baseline to week 12
Steady-State Time to Maximum
Time Frame: From baseline to week 12
From baseline to week 12
Area under the curve (AUC)
Time Frame: From baseline to week 12
From baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-CL-01008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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