Efficacy and Safety of Filgotinib in Active Ulcerative Colitis

• Research type

  Research Study

• Full title

  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

• IRAS ID

  209261

• Contact name

  Ian Beales

• Contact email

  ian.beales@nnuh.nhs.uk

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2016-001392-78

• Clinicaltrials.gov Identifier

  129647, IND

• Duration of Study in the UK

  2 years, 10 months, 31 days

• Research summary

  This is a randomised, double-blind, placebo-controlled study investigating treatment of Ulcerative Colitis (UC). 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 approximately 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 (the study medication) is effective and safe in treating people with moderate to severe ulcerative colitis (UC).

  In this study, approximately 1300 male and female patients will be enrolled, aged 18 to 75, at around 400 centres worldwide.

  During the first part (induction), participants will be randomly assigned to one of following treatment groups:
  • Treatment 1: filgotinib 200 mg daily
  • Treatment 2: filgotinib 100 mg daily
  • Treatment 3: placebo daily

  After 11 weeks, depending on the treatment group assigned during part one (induction), patients will then be assigned to another treatment group for the second part of the study (maintenance).

  Eligible participants will visit the clinic at least 13 times (19 times if the participant is a woman who can get pregnant) over 58 weeks. They will undergo various study procedures to assess the safety and effectiveness of filgotinib. Depending on their treatment response at or after week 10, there may be an option to then enrol in a Long Term Extension study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  16/SC/0600

• Date of REC Opinion

  8 Dec 2016

• REC opinion

  Further Information Favourable Opinion