Testicular Safety of Filgotinib in Males with IBD
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease
IRAS ID
227259
Contact name
Tim Raine
Contact email
Sponsor organisation
Gilead Sciences, Inc
Eudract number
2017-000402-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
129647, IND
Duration of Study in the UK
4 years, 10 months, 1 days
Research summary
Ulcerative Colitis (UC) is an inflammatory disease of the colon and rectum which results in increased frequency of bowel action, rectal bleeding and urgency of defecation. 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. On average in the EU, UC affects approximately 150 out of 100,000 people.
This is a randomised, double-blind, placebo-controlled phase 2 study in adult males with moderately to severely active UC who may be on protocol-specified therapy. While providing a treatment option for participants, this study seeks to evaluate the impact, if any, of filgotinib (the study medication) on spermatogenesis in humans.
Up to 250 males between the ages of 25 and 55 years from 150 sites worldwide will be enrolled. Participants will be randomised in a 1:1 ratio to receive filgotinib 200 mg or placebo once daily. Randomisation will be stratified by concurrent use of methotrexate (MTX). Throughout the duration of the study, participants will be closely monitored to identify any safety concerns or evidence of nonresponse or disease worsening after Week 13. The duration of dosing is up to 26 weeks, and then an additional 195 weeks for those that enter the Long Term Extension (LTE) phase of the study. Participants with more than 50% decline in sperm concentration any time during the study will discontinue study medication, be managed with standard of care and followed in the monitoring phase of the study.
Participants will visit the clinical study site at Screening, Day 1, Week 2, Week 4, Week 8, Week 13, Week 20, and Week 26.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0586
Date of REC Opinion
19 Jan 2018
REC opinion
Further Information Favourable Opinion