NCT07727486尚未招募2 期
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)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 22
- 主要终点
- Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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.
结局指标
主要结局
Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24
时间窗: Baseline, Week 24
次要结局
- Incidence of clinically significant abnormalities in laboratory test results, electrocardiograms (ECGs), vital signs, etc., and changes from baseline.(Through study completion, an average of 1 year)
- Maximum Concentration at Steady State(Cmax,ss)(Through study completion, an average of 1 year)
- Steady-State Time to Maximum(Through study completion, an average of 1 year)
- Area under the curve (AUC)(Through study completion, an average of 1 year)
- Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period.(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.(Baseline, Week 24)
- Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period.(Baseline, Week 24)
- Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period.(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.(Baseline, Week 24)
- Treatment-emergent adverse events.(Through study completion, an average of 1 year)
研究者
研究点 (22)
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