Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Fistulizing Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT03077412
- Run by
- Gilead Sciences
- People needed
- 57
- Starts
- 2017-04-06
- Expected to finish
- 2021-02-17
- Last updated by the study team
- 2022-04-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Miami Crohn's and Colitis Center — Miami, Florida, United States
- Center for Interventional Endoscopy - Florida Hospital — Orlando, Florida, United States
- University of South Florida South Tampa Campus — Tampa, Florida, United States
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
- University of Louisville Clinical Trials Unit — Louisville, Kentucky, United States
- John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic — Baltimore, Maryland, United States
- Gastro Center of Maryland — Columbia, Maryland, United States
- Gastro One — Germantown, Tennessee, United States
- Vanderbilt University Medical Center - IBD Clinic — Nashville, Tennessee, United States
- Texas Clinical Research Institute — Arlington, Texas, United States
- DHAT Research Institute — Garland, Texas, United States
- Texas Digestive Disease Consultants — Southlake, Texas, United States
- McGuire DVAMC — Richmond, Virginia, United States
- Klinikum Klagenfurt am Wörthersee — Klagenfurt, Austria
- Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology — Vienna, Austria
- Universitaire Ziekenhuizen Leuven — Leuven, Belgium
- Mount Sinai Hospital — Toronto, Canada
- Toronto Digestive Disease Associates Inc. — Toronto, Canada
- CHU Grenoble Alpes - Hopital Michallon (main office) — La Tronche, France
- CHU de Rennes - Hôpital Pontchaillou (main office) — Rennes, France
- CHU Nancy - Hopital de Brabois — Vandœuvre-lès-Nancy, France
- Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany
- Universitatsklinkum Jena — Jena, Germany
- Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza — Békéscsaba, Bekes County, Hungary
- Bugát Pál Kórház, Gasztroenterológiai osztály — Gyöngyös, Heves County, Hungary
Full record on ClinicalTrials.gov
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