NCT07335055
招募中
2 期
A Phase 2 Randomized, Double-blind, Placebo-Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of HSK47388 in Participants With Moderately to Severely Active Ulcerative Colitis
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The proportion of patients with clinical response
概览
简要总结
The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained
- •Male or female, ≥18 years old and ≤75 years old
- •Willing and able to comply with study-specific procedures and the requirements of study protocol.
- •Diagnosis of ulcerative colitis (UC)
- •Baseline modified Mayo score of 5 to 9 and the endoscopy subscore 2 to 3
- •Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy or advanced therapy.
排除标准
- •Subjects have used treatments within the time frame specified in protocol prior to the baseline visit
- •Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
- •Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
- •Presence of a stoma
- •Presence or history of a fistula
- •Intra-abdominal or other major surgery performed within 12 weeks before baseline
- •History of extensive colonic resection
- •Subjects have laboratory values meeting the criteria in protocol
- •Concurrent conditions and history of other diseases as described in protocol
研究组 & 干预措施
HSK47388-Dose level 1
Experimental
干预措施: HSK47388 (Drug)
HSK47388-Dose level 2
Experimental
干预措施: HSK47388 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of patients with clinical response
时间窗: Week 12
次要结局
- The proportion of patients with clinical remission(Week 12)
- The proportion of patients with symptomatic remission(Week 12)
- The proportion of patients with endoscopic remission(Week 12)
- Proportion of patients with Mayo endoscopic subscore 0(Week 12)
- Percent change from baseline in Mayo score and modified Mayo score(Week 12)
- Percent change from baseline in partial Mayo score(Week 12)
研究者
研究点 (1)
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