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

InnoCare Pharma

Status and phase: Not yet enrolling; Phase 2

Conditions: Cutaneous Lupus Erythematosus (CLE)

Treatments: Other: ICP-488 Placebo; Drug: ICP-488 Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07440537

ICP-CL-01008

Details and patient eligibility

About

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).

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups, including a placebo group

ICP-488 Dose A

Experimental group

Treatment:

Drug: ICP-488 Tablets

Drug: ICP-488 Tablets

ICP-488 Dose B

Experimental group

Treatment:

Drug: ICP-488 Tablets

Drug: ICP-488 Tablets

ICP-488 Placebo

Placebo Comparator group

Treatment:

Other: ICP-488 Placebo