Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Completed · Phase 2 · Has a placebo group
Conditions studied: Small Bowel Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT03046056
- Run by
- Gilead Sciences
- People needed
- 78
- Starts
- 2017-04-11
- Expected to finish
- 2020-07-20
- Last updated by the study team
- 2021-08-23
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 lnterventional Endoscopy- Florida Hospital — Orlando, Florida, United States
- University of South Florida South Tampa campus — Tampa, Florida, United States
- Indiana University Health University Hospital — Indianapolis, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Gastro Center of Maryland — Columbia, Maryland, United States
- Meritus Center for Clinical Research — Hagerstown, Maryland, United States
- Clinical Research Institute of Michigan — Chesterfield, Michigan, United States
- Fargo Gastroenterology and Hepatology Clinic — Fargo, North Dakota, United States
- Gastro One — Germantown, Tennessee, United States
- Texas Clinical Research Institute — Arlington, Texas, United States
- Gastroenterology Research of San Antonio — San Antonio, Texas, United States
- TDDC San Marcos — San Marcos, Texas, United States
- Texas Digestive Disease Consultants — Southlake, Texas, United States
- McGuire DVAMC — Richmond, Virginia, United States
- Medical University of Innsbruck, Department of Internal Medicine I — Innsbruck, Austria
- Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology — Vienna, Austria
- Universitair Ziekenhuis Antwerpen — Edegem, Belgium
- Centre Hospitalier Chretien — Liège, Belgium
- Mount Sinai Hospital — Toronto, Canada
- PerCuro Clinical Research Ltd. — Victoria, Canada
- Hepato-Gastroenterologie HK, s.r.o. — Hradec Králové, Czechia
- CHU de Toulouse -Hopital Rangueil (Main Office) — Toulouse, Midi-Pyrenees, France
- Gastroenterologie, Hepatologie und Endokrinologie — Hanover, Germany
- Universitatsklinikum Jena — Jena, Germany
Full record on ClinicalTrials.gov
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