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

Official 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)

Overview

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).

Interventions

• Drug ICP-488 Tablets
  Patients will receive ICP-488 orally as per the protocol
• Drug ICP-488 Tablets
  Patients will receive ICP-488 orally as per the protocol
• Other ICP-488 Placebo
  Patients will receive ICP-488 Placebo orally as per the protocol.

Primary outcome measures

• 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 outcome measures (9)

• 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]
• 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]
• The average change of the CLASI-A score from the baseline value at each visit. [Time frame: 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]
• Adverse events that occurred during treatment. [Time frame: 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]
• Maximum Concentration at Steady State(Cmax,ss) [Time frame: From baseline to week 12]
• Steady-State Time to Maximum [Time frame: From baseline to week 12]
• Area under the curve (AUC) [Time frame: From baseline to week 12]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 27 centers

• The First Affiliated Hospital of Anhui Medical University — Hefei
• Peking University First Hospital — Beijing
• Xuanwu Hospital Capital Medical University — Beijing
• The First Affiliated Hospital of Chongqing Medical University — Chongqing
• Chongqing Hospital of Traditional Chinese Medicine — Chongqing
• The First Affiliated Hospital of Fujian Medical University — Fuzhou
• Dongguan people's hospital — Dongguan
• Dermatology Hospital of Southern Medical University — Guangzhou
• … and 19 more centers

Identifiers

NCT: NCT07440537 · ICP-CL-01008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗