At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 57 enrolled
Drug / intervention
Filgotinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
In Brief
A Phase 2 clinical trial evaluating Filgotinib and Placebo to match filgotinib for Fistulizing Crohn's Disease. Completed, enrolled 57 participants across 27 sites in 9 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFistulizing Crohn's Disease
CountriesAustria, Belgium, Canada, France, Germany, Hungary, Italy, United Kingdom, United States
CollaboratorsLakefront Biotherapeutics NV
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartApr 2017
Primary CompletionJan 2021
Study CompletionFeb 2021
TodayJul 2026
First PostedMar 13, 2017
Enrollment StartApr 6, 2017
Primary CompletionJan 20, 2021
Study CompletionFeb 17, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.3 years ago
Interventions
Filgotinibdrug
Tablet(s) administered orally once daily
Placebo to match filgotinibdrug
Tablet(s) administered orally once daily