NCT05479058

A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over and randomized in this study. The primary objective of this study was to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib once daily for whom the dose was decreased to 100 mg once daily compared to participants remaining on 200 mg once daily.

Detailed description

Participants were planned to receive the blinded treatment until primary analysis time point. After unblinding at the study primary analysis time point, participants would have received unblinded treatment. The clinical trial was originally designed with the primary endpoint to be assessed at Week 48. Due to early termination of the study, none of the participants completed 48 weeks of treatment. All participants participated in blinded treatment period only and the study was unblinded globally after study completion.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Filgotinib	Administered orally once daily
DRUG	Placebo	Administered orally once daily

Timeline

• Start date: 2022-07-26
• Primary completion: 2023-10-09
• Completion: 2023-10-09
• First posted: 2022-07-29
• Last updated: 2024-10-04
• Results posted: 2024-10-04

Locations

50 sites across 13 countries: United States, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, South Africa, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study