CTRI/2017/08/009475进行中（未招募）3 期
Combined Phase 2b/3, Double-Blind, Randomized,Placebo-Controlled Studies Evaluating the Efficacy and Safety ofFilgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
- 试验地点
- 45
- 主要终点
- Primary Outcome Measure:
研究概览
简要总结
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis 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 that is, Gilead Study GS-US-418-3899
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified 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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in either the Cohort A or B Induction Study.
- •Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2) Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit 3) Females of childbearing potential (as defined in Appendix 6) must have a negative pregnancy test at screening and baseline 4) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 6 5) Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge.
- •Documentation should include endoscopic and histopathologic evidence of UC as follows: a) The criteria for documentation of UC based on endoscopy will be medical record documentation of, or an ileocolonoscopy (full colonoscopy with the intubation of the terminal ileum) report dated ≥ 6 months before enrollment, which shows features consistent with UC, determined by the procedure performing physician b) The criteria for documentation of UC based on histopathology will be medical record documentation of or a histopathology report indicating features consistent with UC as determined by the pathologist 6) A surveillance colonoscopy is required at screening in subjects with a history of UC for 8 or more years, if one was not performed in the prior 24 months.
排除标准
- •Key Exclusion Criteria: • Presence of Crohn’s disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon • Active tuberculosis or history of latent TB that has not been treated • Use of any concomitant prohibited medications as described in the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Primary Outcome Measure:
时间窗: Week 10 & Week 58
1. Induction Study: Proportion of Participants Achieving Remission Based on Components of Mayo Clinic Score (MCS) at Week 10
时间窗: Week 10 & Week 58
2. Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Week 58
时间窗: Week 10 & Week 58
次要结局
- Induction Study: Proportion of Participants Achieving MCS Remission at Week 10
- Induction Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10(Week 10)
- Induction Study: Proportion of Participants Achieving Histologic Remission at Week 10(Week 10)
- Induction Study: Proportion of participants achieving MCS remission at Week 10(Week 10)
- Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845(Week 4 postdose and Week 10 predose)
- Maintenance Study: Proportion of Participants Achieving MCS Remission at Week 58(Week 58)
- Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and(58)
- Maintenance Study: Proportion of Participants Achieving 6-Month Corticosteroid-Free Remission Based on(Components of MCS at Week 58)
- Maintenance Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 58(Week 58)
- Maintenance Study: Proportion of Participants Achieving Histologic Remission at Week 58(Week 58)
- Maintenance Study: Proportion of participants achieving MCS remission at Week 58(Week 58)
- Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845(Week 26 (predose or postdose) and Week 58 predose)
研究者
研究点 (45)
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