Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderatelyto Severely Active Crohn’s Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,320
- 试验地点
- 57
- 主要终点
- 1. Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at
研究概览
简要总结
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohns disease in participants who are biologic naive and biologic experienced
Participants who complete the study or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long term extension study GS US 419 3896
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit • Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment • Moderately to severely active CD • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents: corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab.
排除标准
- •â€¢ Current complications of CD such as symptomatic strictures, severe rectal/ anal stenosis, short bowel syndrome, etc.
- •â€¢ Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon • Active tuberculosis (TB) or history of latent TB that has not been treated • Use of any prohibited concomitant medications as described in the study protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
结局指标
主要结局
1. Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at
时间窗: Week 10 | Week 58
Week 10
时间窗: Week 10 | Week 58
[Time Frame: Week 10]
时间窗: Week 10 | Week 58
2. Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10
时间窗: Week 10 | Week 58
3. Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58
时间窗: Week 10 | Week 58
[Time Frame: Week 58]
时间窗: Week 10 | Week 58
4. Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58
时间窗: Week 10 | Week 58
次要结局
- Induction Study: Proportion of Participants Achieving Both Clinical Remission by PRO2 and endoscopic response at(Week 10 (Composite Endpoint))
- Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845(Week 4 postdose and Week 10 predose)
- Induction Study: Proportion of Participants Achieving Clinical Remission by Crohns Disease Activity Index (CDAI) at(Week 10)
- Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58(Week 58)
- Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2 at Weeks 10 and 58(Week 10 & Week 58)
- Maintenance Study: Proportion of Participants Achieving Both Clinical Remission by PRO2 and Endoscopic(Response at Week 58 (Composite Endpoint))
- Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week(58)
- Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845(Week 26 (predose or postdose) and Week 58 predose)