A randomized, double-blind, controlled, multi-center study to evaluate the efficacy and safety of dose de-escalation of orally administered filgotinib in subjects with ulcerative colitis in clinical remission
This is a phase 3 clinical research study aimed at participants included in the SELECTION-LTE study who are in clinical remission and currently taking 200mg of study medication filgotinib once daily. The aim of this study is to see if lowering the dose from 200mg to 100mg per day still helps control ulcerative colitis (UC) and if this is safe. Current therapies developed in the last 2 decades have around 30% non-response rate in patients and a further 30 to 50% of patients will completely stop responding during therapy, highlighting the need for a more efficacious therapy within this patient population.
Approximately 80 participants will be rolled over and randomised (1:1) to receive either filgotinib 100mg once daily or 200mg once daily. Each will be in the study for a minimum of 55 weeks (screening period 21 days followed by 48 weeks of treatment and then 4 weeks follow-up) in countries where filgotinib will become commercially available, and for a maximum duration of 216 weeks (approximately 4 years). For the first 48 weeks, treatment will be blinded after which point treatment will be unblinded and continued. Those participants with a confirmed UC flare will be ‘re-escalated’ to open label 200mg filgotinib daily for at least 12 weeks whilst maintaining the blind for the treatment at randomisation. In these cases, the participant will remain in the study at least until the follow-up visit after the 12 weeks post re-escalation, or until the end of the study in that country, whichever is longer.
Participants will be assessed during the study using blood, urine, stool and bowel (during sigmoidoscopy) samples as well as physical examinations, vital sign monitoring and questionnaires.
Yorkshire & The Humber - Leeds East Research Ethics Committee
Date of REC Opinion
7 Oct 2022
Further Information Favourable Opinion