NCT02914561

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,372 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Filgotinib	Filgotinib tablets administered orally once daily.
OTHER	Placebo	Placebo administered orally once daily.

Timeline

• Start date: 2016-10-31
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2016-09-26
• Last updated: 2023-12-18
• Results posted: 2023-12-18

Locations

513 sites across 41 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study