NCT07753850尚未招募2 期
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SL-325 in Participants With Moderately to Severely Active Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 232
- 主要终点
- Proportion of participants who achieve endoscopic response
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with moderate to severely active Crohn's disease.
The study consists of a screening period of up to 6 weeks, a 12-week induction period, 38-week maintenance period, 52-week long-term extension period, and a 10-week follow-up period.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Crohn's disease confirmed by endoscopy and histopathology ≥ 3 months prior to Screening
- •Moderately to severely active CD as defined by CDAI of ≥ 220 and ≤ 450
- •SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assessed by central review
- •Demonstrated inadequate response, loss of response, or intolerance to one or more of the following Crohn's disease treatments: corticosteroids, immunomodulators, or an approved anti-tumor necrosis factor (TNF), anti-integrin, anti-interleukin (IL)-12/23, anti-interleukin (IL)-23p19, or Janus kinase inhibitor (JAK)
排除标准
- •Diagnosis of UC, indeterminate colitis, or any other gastrointestinal condition that could undermine the diagnosis of CD
- •CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- •Presence or suspicion of any of the following CD complications: intra-abdominal or perianal abscess; symptomatic stricture or colonic stenosis not passable in ileocolonoscopy, fistula, except for perianal fistula; active toxic megacolon or fulminant colitis; short bowel syndrome
- •Surgical bowel resection within 3 months before Screening, ≥ 3 bowel resections, or previous ileo-colonic resection of > 2 segments
- •Diagnosis of primary sclerosing cholangitis
- •Has a stoma, ileostomy, or colostomy.
- •Has prior or current gastrointestinal dysplasia, other than a completely removed low-grade dysplastic lesion.
- •Has active tuberculosis (TB) or inadequately treated latent tuberculosis (LTBI)
- •Prior exposure to any anti-DR3 or anti-TL1A agent or agent with an anti-DR3 or anti-TL1A component
研究组 & 干预措施
SL-325 high dose
Experimental
干预措施: SL-325 (Drug)
SL-325 mid dose
Experimental
干预措施: SL-325 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
SL-325 low dose
Experimental
干预措施: SL-325 (Drug)
结局指标
主要结局
Proportion of participants who achieve endoscopic response
时间窗: Week 12
The proportion of participants who achieve endoscopic response, as defined by a ≥50% decrease in Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline.
次要结局
- Proportion of participants who achieve clinical remission(Week 12)
- Incidence and severity of treatment-emergent adverse events(Week 12)
- Number of participants who discontinue study intervention due to an TEAE(Week 12)
研究者
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