2025-520690-39-00招募中2 期
A Phase IIb, Multicenter, Double-Blind, Placebo-Controlled Induction Study with an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients with Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 44
- 主要终点
- Clinical remission at Week 12, with clinical remission defined as mMS of ≤ 2, with Mayo subscores meeting the following criteria: – Stool frequency subscore ≤ 1 – Rectal bleeding subscore = 0 Endoscopy subscore ≤ 1 (score of 1 modified to exclude friability)
研究概览
简要总结
To evaluate the efficacy of RO7837195 compared with placebo in inducing remission
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of UC established at least 3 months prior to screening, confirmed by clinical and endoscopic evidence during screening
- •Evidence of UC extending a minimum of 15 cm from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening
- •Colonoscopy within 2 years prior to screening or willingness to undergo colonoscopy in lieu of a flexible sigmoidoscopy at screening
- •Moderately to severely active UC, defined as a modified Mayo Score (mMS) of 5-9 including an endoscopic subscore of ≥ 2 during the screening period
- •Agreement to adhere to the contraception requirements
- •Prior advanced therapy failure and/or conventional therapy failure
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
- •Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
- •History of or current ileostomy or colostomy
- •Diagnosis of Crohn’s disease or indeterminate colitis
- •Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- •Diagnosis of toxic megacolon within 12 months prior to screening
结局指标
主要结局
Clinical remission at Week 12, with clinical remission defined as mMS of ≤ 2, with Mayo subscores meeting the following criteria: – Stool frequency subscore ≤ 1 – Rectal bleeding subscore = 0 Endoscopy subscore ≤ 1 (score of 1 modified to exclude friability)
Clinical remission at Week 12, with clinical remission defined as mMS of ≤ 2, with Mayo subscores meeting the following criteria: – Stool frequency subscore ≤ 1 – Rectal bleeding subscore = 0 Endoscopy subscore ≤ 1 (score of 1 modified to exclude friability)
次要结局
- Clinical response at Week 12, with clinical response defined as meeting both of the following sets of criteria: – Decrease from baseline in the mMS of ≥ 2 and ≥ 30% reduction from baseline - Decrease in Mayo rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤1
- Endoscopic improvement at Week 12, with endoscopic improvement defined as a Mayo endoscopy subscore of ≤1 (score of 1 modified to exclude friability)
- Endoscopic remission at Week 12, with endoscopic remission defined as a Mayo endoscopy subscore of 0
- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) grading scale
- Change from baseline in selected vital signs
- Change from baseline in selected clinical laboratory test results
- Serum concentration of RO7837195 at specified timepoints
- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
研究者
US Program Manager Product Development Regulatory
Scientific
Genentech Inc.
研究点 (44)
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