A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 160
- 主要终点
- Number of Participants with Deep Remission at Week 52
研究概览
简要总结
The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
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
- None
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
- •Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
- •Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 but less than or equal to (<=) 450
- •Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) >= 4 (for participants with isolated ileal disease) or >= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:
- •a minimum score of 1 for the component of "size of ulcers" AND
- •a minimum score of 1 for the component of "ulcerated surface"
- •In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
- •Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol
排除标准
- •Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
- •Currently has or is suspected to have an abscess
- •Has an active fistula during screening or at Week 0 with an anticipated need for surgery
- •Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
- •Currently has a malignancy or has a history of malignancy within 5 years before screening
研究组 & 干预措施
Guselkumab
Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.
干预措施: Guselkumab (Drug)
Risankizumab
Participants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.
干预措施: Risankizumab (Drug)
结局指标
主要结局
Number of Participants with Deep Remission at Week 52
时间窗: At Week 52
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (\<) 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (\>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
次要结局
- Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52(At Week 52)
- Number of Participants with Endoscopic Remission at Week 52(At Week 52)
- Number of Participants with Clinical Remission at Week 52(At Week 52)
- Number of Participants with Steroid-Free Clinical Remission at Week 52(At Week 52)
- Number of Participants with Abnormalities in Laboratory Parameters(Up to Week 148)
- Number of Participants With Change From Baseline in Laboratory Abnormalities(Up to week 148)
- Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention(Up to Week 165)