A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 38
- 主要终点
- Percentage of Participants Who Achieved Clinical Remission at Week 24
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study 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, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
- •Moderately or severely active CD
- •Minimum duration of CD of at least 6 months
- •Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
- •Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
- •Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
- •Corticosteroids
- •Immunomodulators
- •Tumor necrosis factor-alpha (TNFα) antagonists
- •Vedolizumab
- •Ustekinumab
- •Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements
排除标准
- •Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
- •Presence of fistulae
- •Evidence of short bowel syndrome
- •Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
- •History of total colectomy, subtotal-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 tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks.
干预措施: Filgotinib (Drug)
Filgotinib 200 mg
Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks.
干预措施: Placebo to match filgotinib (Drug)
Filgotinib 100 mg
Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks.
干预措施: Filgotinib (Drug)
Filgotinib 100 mg
Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks.
干预措施: Placebo to match filgotinib (Drug)
Placebo
PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks.
干预措施: Placebo to match filgotinib (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Clinical Remission at Week 24
时间窗: Week 24
The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of \< 150. A higher score indicates more severe disease.
次要结局
- Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24(Baseline; Week 24)
- Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24(Week 24)
- Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24(Week 24)
- Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24(Week 24)
- Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24(Week 24)
- Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24(Week 24)
- Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10(Week 10)
- Change From Baseline in CDAI Scores at Week 10(Baseline; Week 10)
- Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24(Baseline; Week 24)
- Change From Baseline in Jejunum Segmental MaRIA Score at Week 24(Baseline; Week 24)
- Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24(Week 24)
- Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24(Week 24)
- Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24(Week 24)
- Change From Baseline in CDAI Scores at Week 24(Baseline; Week 24)