CTRI/2026/01/100471招募中2/3 期
A Phase 2b-3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohns Disease
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 789
- 试验地点
- 19
研究概览
简要总结
Crohn’s Disease (CD) is a disease of the digestive system that causes inflammation and ulcers in the intestine (gut). Although there are approved treatment options, participants either do not respond or may not
tolerate them due to side effects. Hence, there is a need for better treatment options.
Overall study consists of 3 separate studies as below:
o Phase 2b Induction Dose-ranging Study (Induction Study 1)
o Phase 3 Induction Study (Induction Study 2)
o Phase 3 Maintenance Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD.
- •2 Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score more than and equal to 220 but less than equal to 450 and either mean daily SF count more than equal to 4, or mean daily AP score more than equal to
- •3 Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD more than equal to 6 for participants with colonic or ileocolonic disease, and SES-CD more than and equal to 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments.
- •4 A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests.
- •5 Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy [ADT]-naïve) or advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD (ADT-inadequate responder [IR]) as defined in the protocol.
排除标准
- •1 Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention.
- •2 Presence of a stoma or ostomy.
- •3 Participants with presence of active fistulas may be included if there is no surgery needed.
- •4 Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline.
- •5 Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization.
研究者
Dr Sanish Davis
Johnson and Johnson Pvt Ltd.
研究点 (19)
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