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

Официальное название

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)

Обзор

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).

Вмешательства

• Препарат ICP-488 Tablets
  Patients will receive ICP-488 orally as per the protocol
• Препарат ICP-488 Tablets
  Patients will receive ICP-488 orally as per the protocol
• Другое ICP-488 Placebo
  Patients will receive ICP-488 Placebo orally as per the protocol.

Первичные конечные точки

• The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16. [Срок оценки: All the subjects completed the 16-week assessment.]

Вторичные конечные точки (9)

• At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50). [Срок оценки: 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. [Срок оценки: From baseline to week 28]
• The average change of the CLASI-A score from the baseline value at each visit. [Срок оценки: From baseline to week 28]
• The percentage change of CLASI-A relative to the baseline at each visit. [Срок оценки: From baseline to week 28]
• Adverse events that occurred during treatment. [Срок оценки: 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. [Срок оценки: From baseline to week 28]
• Maximum Concentration at Steady State(Cmax,ss) [Срок оценки: From baseline to week 12]
• Steady-State Time to Maximum [Срок оценки: From baseline to week 12]
• Area under the curve (AUC) [Срок оценки: From baseline to week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 27 центров

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Peking University First Hospital — Пекин
• Xuanwu Hospital Capital Medical University — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Chongqing Hospital of Traditional Chinese Medicine — Чунцин
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• Dongguan people's hospital — Дунгуань
• Dermatology Hospital of Southern Medical University — Гуанчжоу
• … и ещё 19 центров

Идентификаторы

NCT: NCT07440537 · ICP-CL-01008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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