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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Miami
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Gastro Center of Maryland - Columbia
Columbia, Maryland, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Universitair Ziekenhuis Leuven Campus Gasthuisberg
Leuven, Belgium
Hepato-Gastroenterology HK
Hradec Králové, Czechia
GEP Clinic
Prague, Czechia
CHU Amiens-Picardie
Amiens, France
Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie
Marseille, France
Start Date
July 26, 2022
Primary Completion Date
October 9, 2023
Completion Date
October 9, 2023
Last Updated
October 4, 2024
22
ACTUAL participants
Filgotinib
DRUG
Placebo
DRUG
Lead Sponsor
Galapagos NV
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07185009