CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,372 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.

Search/NCT02914561
NCT02914561Phase 3Completed
CompareCT.gov

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

Lakefront Biotherapeutics NV·interventional·Posted Sep 26, 2016·Updated Dec 18, 2023

In Brief

A Phase 3 clinical trial evaluating Filgotinib and Placebo for Crohn's Disease. Completed, enrolled 1,372 participants across 513 sites in 41 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesArgentina, 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, United States
CollaboratorsGilead Sciences

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 26, 2016
Enrollment StartOct 31, 2016
Primary CompletionNov 11, 2022
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 9.8 years ago

Interventions

Filgotinibdrug

Filgotinib tablets administered orally once daily.

Placeboother

Placebo administered orally once daily.