Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Purpose
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.
Condition
- Small Bowel Crohn's Disease
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Filgotinib 200 mg |
Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks. |
|
|
Experimental Filgotinib 100 mg |
Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks. |
|
|
Placebo Comparator Placebo |
PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks. |
|
More Details
- Status
- Completed
- Sponsor
- Gilead Sciences