Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Completed · Phase 3 · Has a placebo group
Conditions studied: Crohn's Disease
In brief
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).
Key facts
- Study ID
- NCT02914561
- Run by
- Lakefront Biotherapeutics NV
- People needed
- 1372
- Starts
- 2016-10-31
- Expected to finish
- 2022-11-11
- Last updated by the study team
- 2023-12-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Digestive Health - Sun City — Sun City, Arizona, United States
- Southern California Research Center, Inc. — Coronado, California, United States
- VVCRD Research — Garden Grove, California, United States
- UC San Diego Health System — La Jolla, California, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Inland Empire Clinical Trials, LLC — Rialto, California, United States
- Kaiser Permanente — San Francisco, California, United States
- Clearview Medical Research, LLC — Santa Clarita, California, United States
- University of Colorado Denver and Hospital — Aurora, Colorado, United States
- South Denver Gastroenterology, PC — Lone Tree, Colorado, United States
- Connecticut GI, PC-Research Division — Farmington, Connecticut, United States
- Medstar Georgetown University Hospital (Patient Exams) — Washington D.C., District of Columbia, United States
- Advanced Research, LLC — Coral Springs, Florida, United States
- UF Clinical Research Center — Gainesville, Florida, United States
- Florida Research Institute — Lakewood Rch, Florida, United States
- Florida Center for Gastroenterology — Largo, Florida, United States
- University of Miami Crohn's and Colitis Center — Miami, Florida, United States
- Advanced Pharma CR — Miami, Florida, United States
- Cordova Research Institute — Miami, Florida, United States
- Vista Health Research, LLC — Miami, Florida, United States
- Gastroenterology Group of Naples — Naples, Florida, United States
- Center for Interventional Endoscopy - AdventHealth Orlando — Orlando, Florida, United States
- Gulf Region Clinical Research Institute — Pensacola, Florida, United States
- Advanced Medical Research Center — Port Orange, Florida, United States
- Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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