CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,351 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/NCT02914522
NCT02914522Phase 3Completed
CompareCT.gov

Combined Phase 2b/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 Ulcerative Colitis

Gilead Sciences·interventional·Posted Sep 26, 2016·Updated Apr 21, 2021

In Brief

A Phase 3 clinical trial evaluating Filgotinib and PTM filgotinib for Ulcerative Colitis. Completed, enrolled 1,351 participants across 343 sites in 40 countries.

Detailed Summary

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesArgentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsLakefront Biotherapeutics NV

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 26, 2016
Enrollment StartNov 14, 2016
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.8 years ago

Interventions

Filgotinibdrug

Tablet(s) administered orally once daily

PTM filgotinibdrug

Tablet(s) administered orally once daily