ICP-488 for Cutaneous Lupus Erythematosus: a 2nd phase study to test safety and efficacy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ICP-488 tablets in adults with cutaneous lupus erythematosus, including discoid and subacute cutaneous forms. Participants are randomized to receive ICP-488 or placebo over a defined treatment period, with CLASI-A used to measure skin disease activity. Eligibility requires confirmed CLE with at least moderate activity, stable background therapy, and contraception requirements for all potential participants. The study will assess changes in skin disease activity and monitor adverse events to determine tolerability in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Dongguan people's hospital
  Dongguan, Guangdong, China Recruiting
• Dermatology Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Second Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting
• Dermatology Hospital of Jiangxi Province
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Study coordinator: Alexia Lu
• Email: CO_HGRAC@innocarepharma.com
• Phone: 010-66609745

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Afimetoran in Adults With Cutaneous Lupus Erythematosus

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• Long-Term Extension of enpatoran for cutaneous lupus symptoms

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• Quinacrine for Cutaneous Lupus Erythematosus

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  Recruiting Phase 2 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07694336

• S-4321 in adults with autoimmune or immune-mediated diseases

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  Recruiting at 2 sites Phase 1 Seismic Therapeutic AU Pty Ltd · Charlestown, New South Wales and 1 other locations · NCT07455578

• Enpatoran for adults with skin lupus, with or without systemic disease

  This 24-week test will see if enpatoran tablets reduce active skin lesions in adults with cutaneous lupus, with or without systemic lupus.

  Recruiting at 74 sites Phase 3 EMD Serono · Los Angeles, California and 73 other locations · NCT07332481

• Lupus patient registry for better understanding and care

  This study is collecting information from adults with lupus to help improve understanding and care for the disease.

  Recruiting Lupus Foundation of America · Washington D.C., District of Columbia · NCT06927219

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.