Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Completed · Phase 3 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).
Key facts
- Study ID
- NCT02914522
- Run by
- Gilead Sciences
- People needed
- 1351
- Starts
- 2016-11-14
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2021-04-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic Arizona — Scottsdale, Arizona, United States
- VA Long Beach Healthcare System — Long Beach, California, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- South Denver Gastroenterology, PC — Lone Tree, Colorado, United States
- Connecticut GI PC-Research Division — Farmington, Connecticut, United States
- UF Health at Shands Hospital — Gainesville, Florida, United States
- Florida Research Institute — Lakewood Rch, Florida, United States
- University of Miami Crohn's and Colitis Center — Miami, Florida, United States
- Cordova Research Institute — Miami, Florida, United States
- Gastroenterology Group of Naples — Naples, Florida, United States
- Advanced Medical Research Center — Port Orange, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Shafran Gastroenterology Center — Winter Park, Florida, United States
- Florida Medical Clinic, P.A. — Zephyrhills, Florida, United States
- Gastroenterology Associates of Central Georgia, LLC — Macon, Georgia, United States
- Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
- Atlanta Gastroenterology Specialist, PC — Suwanee, Georgia, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Louisville, Clinical Trials Unit — Louisville, Kentucky, United States
- Delta Research Partners, LLC — Monroe, Louisiana, United States
- Louisiana Research Center, LLC — Shreveport, Louisiana, United States
- Investigative Clinical Research — Annapolis, Maryland, United States
- MGG Group Co., Inc., Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
- Gastro Center of Maryland — Columbia, Maryland, United States
- Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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