A Study to Evaluate the Efficacy and Safety of ICP-488 in Participants With Primary Sjögren's Syndrome

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Participants With Primary Sjögren's Syndrome (pSjS)

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in participants with primary Sjögren's syndrome (pSjS).

Вмешательства

• Препарат ICP-488 Tablets
  Specified dose on specified days
• Препарат ICP-488 Placebo
  Specified dose on specified days

Первичные конечные точки

• Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24 [Срок оценки: Baseline, Week 24]

Вторичные конечные точки (10)

• Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period. [Срок оценки: Baseline, Week 24]
• Percentage (%) of participants achieving a reduction from baseline in ESSDAI of ≥3 points at each scheduled visit during the 24-week treatment period. [Срок оценки: Baseline, Week 24]
• Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period. [Срок оценки: Baseline, Week 24]
• Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period. [Срок оценки: Baseline, Week 24]
• Percentage (%) of participants achieving a reduction from baseline in ESSPRI of ≥1 point or 15% at each scheduled visit during the 24-week treatment period. [Срок оценки: Baseline, Week 24]
• Treatment-emergent adverse events. [Срок оценки: Through study completion, an average of 1 year]
• Incidence of clinically significant abnormalities in laboratory test results, electrocardiograms (ECGs), vital signs, etc., and changes from baseline. [Срок оценки: Through study completion, an average of 1 year]
• Maximum Concentration at Steady State(Cmax,ss) [Срок оценки: Through study completion, an average of 1 year]
• Steady-State Time to Maximum [Срок оценки: Through study completion, an average of 1 year]
• Area under the curve (AUC) [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Aged 18 to 70 years inclusive.
• The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years..
• The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5.
• At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL/min OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL/min.
• Positive for anti-Sjögren's-syndrome-related antigen A (anti-SSA/Ro) antibodies at screening.
• Stable treatment regimen that can be continued until the end of study treatment (Week 48).
• Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception correctly during the study treatment period and for 1 month (28 days) after the last dose.
• Male participants with a WOCBP partner must agree to use protocol-specified contraceptive methods during the study treatment period and for 3 days after the last dose.

Критерии исключения

• SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis).
• Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS.
• Presence of any other medical condition associated with SjS symptoms.
• Participants with a history of any clinically significant disease other than pSjS.
• Significant ECG abnormalities at screening requiring treatment.
• Participants with gastrointestinal diseases or gastrointestinal surgery present within 3 months prior to the screening visit that could affect the absorption of the study drug.
• Current or past history of bleeding disorders or diseases related to platelet dysfunction.
• Severe infection (bacterial, fungal, or viral) requiring hospitalization within 60 days prior to screening.
• Participants with any uncontrolled clinically significant laboratory abnormality that, in the opinion of the investigator, could affect the interpretation of study data or the participant's participation in the study.
• Participants considered by the investigator to be unsuitable for participation in this study for any reason.

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 · 22 центра

• Peking — Пекин
• Chongqing Traditional Chinese Medicine Hospital — Чунцин
• "Southwest Hospital, Army Medical University （The First Hospital Affiliated to Army Medica — Чунцин
• The First Affiliated Hospital of Xiamen University — Xiamen
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• The First Affiliated Hospital of Guangxi Medical University — Nanning
• The Second Hospital of Hebei Medical University — Shijiazhuang
• … и ещё 14 центров

Идентификаторы

NCT: NCT07727486 · ICP-CL-01010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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