Long Term Safety of Filgotinib in Active Ulcerative Colitis
Research type
Research Study
Full title
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis
IRAS ID
209260
Contact name
Ian Beales
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2016-002765-58
Clinicaltrials.gov Identifier
129647, IND
Duration of Study in the UK
5 years, 9 months, 26 days
Research summary
This is long term extension study investigating treatment of Ulcerative Colitis (UC) with filgotinib (the study medication). UC is an inflammatory disease of the colon and rectum which results in increased frequency of bowel action, rectal bleeding, and urgency of defecation. On average in the EU, UC affects 150 out of 100,000 people. UC is a chronic condition which means that it is ongoing and life-long, although sufferers might experience periods of good health (remission), as well as times when symptoms are more active (relapses). There is no cure for UC, but there are treatments that can help to settle relapses and keep symptoms away for longer. The purpose of this study is to see if filgotinib is safe in the long term, treating people with moderate to severe ulcerative colitis (UC) and to give participants from study GS-US-418-3898 the chance to continue on filgotinib.
In this study, approximately 1000 male and female patients from the previous study will be enrolled, aged 18 to 75, from approximately 400 centres worldwide.
The participants will continue on the same dose as they finished the previous study unless they had no response or their disease worsened, in which case they will take 200 mg filgotinib daily.
The participants will visit the clinic at least 15 times (37 times if the participant is a woman who can get pregnant) over 144 weeks. They will undergo various study procedures to assess the safety of filgotinib.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0601
Date of REC Opinion
8 Dec 2016
REC opinion
Further Information Favourable Opinion