A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 11
- 主要终点
- Induction study (adult): Clinical remission at Week I-12 Maintenance study (adult): Clinical remission at Week M-40 Adolescent study: Clinical remission at Week M-40
研究概览
简要总结
Induction study (adult): To evaluate the efficacy of icotrokinra versus placebo in inducing clinical remission Maintenance study (adult): To evaluate the efficacy of a maintenance regimen of icotrokinra versus placebo in achieving clinical remission in participants with moderately to severely active UC who were induced into clinical response with icotrokinra Adolescent study: To evaluate the efficacy of a maintenance regimen of icotrokinra in achieving clinical remission in adolescent participants with moderately to severely active UC who were induced into clinical response with icotrokinra
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult participants: ≥18 years of age (and at least the legal age of consent in the jurisdiction in which the study is taking place). Adolescent participants: ≥12 to <18 years of age, at the time of signing the informed assent/consent
- •Diagnosis of UC established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
- •Moderately to severely active UC, defined as baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy.
- •An endoscopy subscore ≥2 as obtained during central review of the screening video endoscopy.
- •5.A participant who has had extensive UC for ≥8 years, or disease limited to the left side of the colon for ≥ 10 years before the first dose of study intervention must undergo a complete colonoscopy to assess for the presence of dysplasia within 1 year before the first dose of study intervention. Completion of the colonoscopy with dysplasia assessment is allowed during the screening period prior to the first dose of study intervention.
排除标准
- •Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study.
- •Presence of a stoma.
- •Presence or history of fistula.
- •Colonic resection within 24 weeks before baseline or any other intra abdominal or other 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).
结局指标
主要结局
Induction study (adult): Clinical remission at Week I-12 Maintenance study (adult): Clinical remission at Week M-40 Adolescent study: Clinical remission at Week M-40
Induction study (adult): Clinical remission at Week I-12 Maintenance study (adult): Clinical remission at Week M-40 Adolescent study: Clinical remission 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