Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Purpose
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.
Condition
- Fistulizing 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, 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
Exclusion Criteria
- 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.
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 + placebo to match filgotinib 100 mg for 24 weeks |
|
|
Experimental Filgotinib 100 mg |
Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks |
|
|
Experimental Placebo |
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks |
|
More Details
- Status
- Completed
- Sponsor
- Gilead Sciences