CTRI/2019/06/019738进行中（未招募）2/3 期
A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohns Disease.
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 980
- 试验地点
- 14
- 主要终点
- - Clinical response at Week 12 and clinical remission at Week 48
研究概览
简要总结
The purpose of this study is to evaluate theclinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety ofguselkumab in participants with Crohn’s disease. This program consists of two48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). Participants whocomplete the 48-week Phase 3 studies may be eligible to enter the long termextension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic,biomarkers, and safety will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Have Crohns disease (CD) or fistulizing Crohns disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.
- •Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohns Disease (SES-CD) 3) Have screening laboratory test results within the protocol specified parameters 4) A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline 5) Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.
排除标准
- •Current diagnosis of ulcerative colitis or indeterminate colitis 2) Has complications of Crohns disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation 3) Unstable doses of concomitant Crohns disease therapy 4) Receipt of Crohns disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 8 weeks prior to baseline (or within 5 half-lives of baseline, whichever is longer) 5) Prior exposure to p40 inhibitors or p19 inhibitors 6) Any medical contraindications preventing study participation.
结局指标
主要结局
- Clinical response at Week 12 and clinical remission at Week 48
时间窗: Week 12 and Week 48
- Clinical response at Week 12 and endoscopic response at Week 48
时间窗: Week 12 and Week 48
次要结局
- Endoscopic response at Week 48(Week 48)
- Clinical remission at Week 48 and endoscopic response at Week 48(Week 48)
- Endoscopic remission (Global definition) at Week 48(Week 48)
- Deep remission (Global definition) at Week 48(Week 48)
- Clinical remission at Week 12(Week 12)
- Clinical response at Week 4(Week 4)
- Endoscopic response at Week 12(Week 12)
- Fatigue response at Week 12(Week 12)
- Clinical remission at Week 12 and endoscopic response at Week 12(Week 12)
- Endoscopic remission (Global definition) at Week 12(Week 12)
- Clinical response at Week 12 and corticosteroid-free clinical remission at Week 48(Week 12 and 48)
- Clinical response at Week 12 and endoscopic remission (Global definition) at Week 48(Week 12 and 48)
- Clinical remission at Week 48(Week 48)
研究者
研究点 (14)
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