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
- 224
- 试验地点
- 114
- 主要终点
- Percentage of Participants With Clinical Remission at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.
详细描述
This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ulcerative colitis (UC) established at least 3 months
- •Moderately to severely active UC assessed by mMS
- •Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC
排除标准
- •Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
- •Diagnosis of Crohn's disease or indeterminate colitis
- •Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
- •Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23
研究组 & 干预措施
RO7837195 Dose Regimen 4
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
干预措施: RO7837195 (Drug)
RO7837195 Dose Regimen 3
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
干预措施: RO7837195 (Drug)
RO7837195 Matched Placebo/ RO7837195
Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively.
干预措施: RO7837195 (Drug)
RO7837195 Matched Placebo/ RO7837195
Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively.
干预措施: RO7837195 Matched Placebo (Drug)
RO7837195 Dose Regimen 1
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
干预措施: RO7837195 (Drug)
RO7837195 Dose Regimen 2
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
干预措施: RO7837195 (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Remission at Week 12
时间窗: At Week 12
Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1.
次要结局
- Serum Concentration of RO7837195(Up to Weeks 65)
- Percentage of Participants With Clinical Response at Week 12(At Week 12)
- Percentage of Participants With Endoscopic Improvement at Week 12(At Week 12)
- Percentage of Participants With Endoscopic Remission at Week 12(At Week 12)
- Number of Participants With Adverse Events (AEs)(Up to Weeks 65)
- Percentage of Participants With Anti-drug Antibodies to RO7837195(Up to Weeks 65)