GS-US-419-4016 Filgotinib in treatment of Perianal Fistulizing Crohns
Research type
Research Study
Full title
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
IRAS ID
220649
Contact name
Nick Kennedy
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-003153-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 13 days
Research summary
This is a Phase 2, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of filgotinib in treating participants with perianal fistulising Crohn’s disease (CD). Approximately 75 participants aged 18 to 75 years with perianal fistulising CD will be randomised from 10 participating countries to one of three treatment groups in a 2:2:1 ratio to either filgotinib 200mg, filgotinib 100mg, or matching placebo.
After taking the study medication for 10 weeks, the study doctor will check each participant's Crohn’s disease to see how it is doing compared to the beginning of the study. If the disease shows improvement, participants will continue on their current, blinded treatment assignment for the remainder of the study. If the disease has not improved by Week 10, participants will stop taking the current study medication and then, if eligible, will enter a separate long term extension (LTE) study.
Following Week 10, if a subject's Crohn’s disease worsens, the participant may be discontinued from the study and may have the option to enter into the LTE study as well.
End of Study is defined as when the last participant has completed 24 weeks of treatment plus 30 days follow-up. All participants will have Magnetic Resonance Imaging (MRI) and an endoscopy at the start and end of the study.
The primary objective of the study is to evaluate if filgotinib is an effective treatment in improving perianal fistulising CD after 24 weeks of treatment compared to placebo. The secondary objectives include evaluating how effective filgotinib is in establishing combined fistula remission and proctitis remission at week 24 when compared to placebo and the time taken to achieve clinical fistula response, remission and first fistula closure. The study will also assess the safety and tolerability of filigotinib in all participants.
Participants will be given the option to take part in a genomic substudy, they will be asked to donate a single blood sample.
Participants will also have the option to donate leftover blood samples from the main study for future research purposes. Separate consent is obtained for these substudies.REC name
HSC REC B
REC reference
17/NI/0113
Date of REC Opinion
25 Jul 2017
REC opinion
Further Information Favourable Opinion