Trials / Completed
CompletedNCT03046056
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (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, 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.
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
- 2017-04-11
- Primary completion
- 2020-07-20
- Completion
- 2020-07-20
- First posted
- 2017-02-08
- Last updated
- 2021-08-23
- Results posted
- 2021-08-09
Locations
38 sites across 12 countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03046056. Inclusion in this directory is not an endorsement.