Phase 2
Completed N=57
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Fistulizing Crohn's Disease
Source: ClinicalTrials.gov NCT03077412 ↗
Enrolled (actual)
57
Serious AEs
14.0%
Results posted
Apr 2022
Primary outcomePrimary: Percentage of Participants Who Achieved Combined Fistula Response at Week 24 — 47.1; 29.2; 25.0 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Combined Fistula Response at Week 24 |
47.1; 29.2; 25.0 | — |
| SECONDARY Percentage of Participants Who Achieved Combined Fistula Remission at Week 24 |
47.1; 25.0; 16.7 | — |
| SECONDARY Time to Clinical Fistula Response up to Week 24 |
15; 16; 35.5 | — |
| SECONDARY Time to Clinical Fistula Remission up to Week 24 |
15; 29; 71 | — |
| SECONDARY Percentage of Participants Who Achieved Proctitis Remission at Week 24 |
10.0; 15.4; 28.6 | — |
Eligibility Criteria
Key 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
Key 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.
Data sourced from ClinicalTrials.gov (NCT03077412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.