Long Term Safety of Filgotinib in Active Crohn’s Disease
Research type
Research Study
Full title
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease
IRAS ID
209258
Contact name
Ian Beales
Contact email
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2016-002763-34
Clinicaltrials.gov Identifier
129646, IND
Duration of Study in the UK
5 years, 9 months, 26 days
Research summary
Research Summary:
This is a long term extension study investigating the treatment of Crohn’s disease (CD) with filgotinib (the study medication). CD is an inflammatory bowel disease of the gastrointestinal tract (digestive tract) that causes sufferers to have symptoms of diarrhoea, abdominal pain, weight loss and the passage of blood through the rectum. In the United States and Europe it is suggested that up to 1.5 million individuals may be affected. CD is a chronic condition which means that it is ongoing and life-long, although suffers might have periods of good health (remission), as well as times when symptoms are more active (relapses). There is no a cure for CD, 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 CD and to give participants from other Gilead studies i.e. GS-US-419-3895 the chance to continue on filgotinib.In this study, approximately 1000 male and female patients will be enrolled, aged 18 to 75, at around 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.
Lay Summary:
DIVERSITY-LTE was a phase 3 long-term extension (LTE) study, the primary objective of which was to observe the long-term safety of filgotinib in subjects with Crohn’s disease, who had previously participated in and completed one of the parent studies (DIVERGENCE 1, DIVERGENCE 2 or DIVERSITY 1). Participants continued on the same dose of filgotinib as they had been receiving during the parent study (either 100 or 200 mg), but now were unblinded meaning they knew which treatment and dose they were receiving. Participants were assessed on Day 1, on Treatment Visits in Weeks 2, 4, 12 and every 12 weeks thereafter, and then 30 days after the last dose of the study drug. The study was prematurely ended because the primary endpoint of the DIVERSITY 1 study was not met.Both physician-assessed Crohn’s Disease Activity Index (CDAI) and Patient-Reported Outcome (PRO-2) scores decreased (i.e. improved) throughout the study compared to before (at baseline) in both filgotinib treatment groups. For the placebo group, these scores stayed around the baseline value up to Week 240, and the average PRO-2 score remained stable throughout the study. For patients who did not respond to the induction dose of filgotinib in the parent study, the mean CDAI and PRO-2 scores showed a rapid decrease initially from baseline, but gradually increased throughout the end of the study due to subjects who discontinued the study early, or remained stable throughout the end of the study. Contrastly, this trend was not observed in CDAI and PRO2 scores in induction non-responders from the parent study who continued on 100 mg filgotinib in the LTE study after induction with 100 mg filgotinib. The most pronounced decreased from baseline in CDAI and PRO2 scores was seen in induction non-responders who had received induction with the placebo. These participants received active study medication for the first time in the LTE study and are therefore expected to have the most pronounced improvement.
The overall assessment of the study’s primary objective is that long-term treatment with filgotinib 200 mg and 100 mg was well-tolerated, and no new safety concerns were identified.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
16/SC/0631
Date of REC Opinion
4 Jan 2017
REC opinion
Further Information Favourable Opinion