A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 349
- 主要终点
- Percentage of Participants with Clinical Response at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo 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
- Double (Participant, Investigator)
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
- •Signed informed consent form 18 years of age or older
- •Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
- •Moderately to severely active UC as per the modified Mayo score
- •Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
排除标准
- •Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
- •UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
- •Presence of a stoma
- •Presence or history of fistula
- •History of extensive colonic resection (example, <30 cm of colon remaining)
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
研究组 & 干预措施
Group 4: Placebo
Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.
干预措施: Placebo (Drug)
Group 4: Placebo
Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.
干预措施: JNJ-77242113 (Drug)
Group 2: JNJ-77242113 Dose-2
Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
干预措施: JNJ-77242113 (Drug)
Group 1: JNJ-77242113 Dose-1
Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.
干预措施: JNJ-77242113 (Drug)
Group 3: JNJ-77242113 Dose-3
Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
干预措施: JNJ-77242113 (Drug)
结局指标
主要结局
Percentage of Participants with Clinical Response at Week 12
时间窗: Week 12
Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
次要结局
- Percentage of Participants with Clinical Remission at Week 12(Week 12)
- Percentage of Participants with Symptomatic Remission at Week 12(Week 12)
- Percentage of Participants with Endoscopic Improvement at Week 12(Week 12)
- Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12(Week 12)
- Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)(Up to Week 76)