2025-521382-27-00招募中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 Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 265
- 试验地点
- 98
- 主要终点
- Phase 2b Induction: clinical response at Week I-12 Phase 3 Induction: Co-primary endpoints - Clinical remission at Week I-12 - Endoscopic response at Week I-12 Phase 3 Maintenance: co-primary endpoints: - Clinical remission at Week M-40 - Endoscopic response at Week M-40
研究概览
简要总结
Phase 2b (induction): To evaluate the efficacy of icotrokinra versus placebo in inducing clinical response Phase 3 (induction): To evaluate the efficacy of icotrokinra versus placebo in induction Phase 3 (maintenance): To evaluate the efficacy of icotrokinra versus placebo in maintenance
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years (or the legal age of consent in the jurisdiction in which the study is taking place).
- •Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD. The participant must have endoscopic evidence of colitis, ileitis, or ileocolitis. Histopathology results supporting the diagnosis of CD, if unavailable, may be obtained during screening and should be interpreted locally.
- •Moderately to severely active CD based on CDAI criteria, defined as: Baseline (Week I-0) CDAI score ≥220 but ≤450 AND EITHER: Mean daily SF count ≥4, based on the unweighted CDAI component of the number of liquid or very soft stools OR Mean daily AP score ≥2, based on the unweighted CDAI component of abdominal pain.
- •Moderately to severely active CD based on SES-CD criteria, defined as: 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 ≥6 for participants with colonic or ileocolonic disease, and SES-CD ≥4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments (ie, ileum, right colon, transverse colon, left colon, rectum), 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”.
- •Demonstrated an inadequate response, loss of response, or intolerance to previous conventional therapy (ADT-naïve) or ADT (defined as biologics and/or advanced oral agents for the treatment of CD; ADT-IR): Conventional therapies: In the absence of an approved label, conventional therapies used to qualify a participant as having had an inadequate response, loss of response or intolerance must have been used in a manner consistent with the dose and regimens as provided in Section 10.
- •a. Oral corticosteroids (including budesonide and beclomethasone dipropionate) b. Thiopurines (ie, AZA, 6-MP, thioguanine) or MTX Note: A history of oral corticosteroid dependence also satisfies the criterion of inadequate response and is described in Section 10.
- •Advanced therapies (biologics or oral advanced therapies): Advanced therapies used to qualify a participant as having had an inadequate response, loss of response, or intolerance must be approved for the treatment of CD in the country of use. c. Anti-tumor necrosis factor alpha (TNFα) antibodies (ie, infliximab, adalimumab, certolizumab or biosimilars) d. Anti-integrin antibodies (ie, vedolizumab, or biosimilars) e. Anti-interleukin 12/23 antibodies (p40) (ie, ustekinumab or biosimilars) f. JAK inhibitors (ie, upadacitinib)
排除标准
- •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.
- •Colonic resection within 24 weeks before baseline or any other intra-abdominal or major surgery performed within 12 weeks before baseline
- •History or screening colonoscopy finding of high or low grade colonic mucosal dysplasia in an area of known colitis (active or historic). Participants will not be excluded for a pathology finding of indefinite dysplasia with reactive atypia.
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, UC or clinical findings highly suggestive of UC.
- •Presence of a draining or functioning stoma or ostomy.
结局指标
主要结局
Phase 2b Induction: clinical response at Week I-12 Phase 3 Induction: Co-primary endpoints - Clinical remission at Week I-12 - Endoscopic response at Week I-12 Phase 3 Maintenance: co-primary endpoints: - Clinical remission at Week M-40 - Endoscopic response at Week M-40
Phase 2b Induction: clinical response at Week I-12 Phase 3 Induction: Co-primary endpoints - Clinical remission at Week I-12 - Endoscopic response at Week I-12 Phase 3 Maintenance: co-primary endpoints: - Clinical remission at Week M-40 - Endoscopic response at Week M-40
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (98)
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