Trials / Completed
CompletedNCT03077412
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Filgotinib | Tablet(s) administered orally once daily |
| DRUG | Placebo to match filgotinib | Tablet(s) administered orally once daily |
Timeline
- Start date
- 2017-04-06
- Primary completion
- 2021-01-20
- Completion
- 2021-02-17
- First posted
- 2017-03-13
- Last updated
- 2022-04-08
- Results posted
- 2022-04-08
Locations
27 sites across 9 countries: United States, Austria, Belgium, Canada, France, Germany, Hungary, Italy, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03077412. Inclusion in this directory is not an endorsement.