Trials / Active Not Recruiting
Active Not RecruitingNCT02914535
Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,173 (actual)
- Sponsor
- Alfasigma S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Filgotinib | Tablet(s) administered orally once daily |
| DRUG | Placebo | Tablet(s) administered orally once daily |
Timeline
- Start date
- 2017-02-23
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2016-09-26
- Last updated
- 2025-02-06
Locations
323 sites across 39 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02914535. Inclusion in this directory is not an endorsement.