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NCT Number: NCT07440537

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

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).

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Key information

Conditions

Cutaneous Lupus Erythematosus (CLE) Connective Tissue Diseases Lupus Erythematosus, Cutaneous Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

9.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.

Treatment and study plan

ICP-488 Tablets

Drug

Patients will receive ICP-488 orally as per the protocol

ICP-488 Placebo

Other

Patients will receive ICP-488 Placebo orally as per the protocol.

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.

    Time frame: All the subjects completed the 16-week assessment.

Secondary outcomes

  1. 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

  2. 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

  3. The average change of the CLASI-A score from the baseline value at each visit.

    Time frame: From baseline to week 28

  4. The percentage change of CLASI-A relative to the baseline at each visit.

    Time frame: From baseline to week 28

  5. Adverse events that occurred during treatment.

    Time frame: From baseline to week 28

  6. 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

  7. Maximum Concentration at Steady State(Cmax,ss)

    Time frame: From baseline to week 12

  8. Steady-State Time to Maximum

    Time frame: From baseline to week 12

  9. Area under the curve (AUC)

    Time frame: From baseline to week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Alexia Lu

CONTACT

[email protected]

010-66609745

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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