A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 27
- 主要终点
- Percentage of Participants Who Achieved Combined Fistula Response at Week 24
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
- •Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
- •Has draining perianal fistulae as a complication of CD, confirmed by magnetic resonance imaging (MRI) at screening
- •Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
- •Antibiotics AND/OR
- •Immunomodulators AND/OR
- •Tumor necrosis factor α (TNFα) Antagonist
- •Is willing and able to undergo MRI per protocol requirements
- •Is willing and able to undergo flexible sigmoidoscopy per protocol requirements
排除标准
- •Presence of current rectovaginal anovaginal or enterovesicular fistulae
- •Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
- •History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
- •Use of any prohibited concomitant medications as described in the study protocol
- •Active tuberculosis (TB) or history of latent TB that has not been treated
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Filgotinib 200 mg
Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
干预措施: Filgotinib (Drug)
Filgotinib 200 mg
Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
干预措施: Placebo to match filgotinib (Drug)
Filgotinib 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks
干预措施: Filgotinib (Drug)
Filgotinib 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks
干预措施: Placebo to match filgotinib (Drug)
Placebo
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
干预措施: Placebo to match filgotinib (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Combined Fistula Response at Week 24
时间窗: Week 24
Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections \> 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
次要结局
- Percentage of Participants Who Achieved Combined Fistula Remission at Week 24(Week 24)
- Percentage of Participants Who Achieved Proctitis Remission at Week 24(Week 24)
- Time to Clinical Fistula Response up to Week 24(Time from treatment start to first visit when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieved perianal fistula closure up to Week 24)
- Time to Clinical Fistula Remission up to Week 24(Time from treatment start to first visit when perianal fistula closure takes place of all external openings that were draining at baseline up to Week 24)