drugset / Trial / NCT05479058

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

NCT05479058

Phase 3 Terminated 22 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-07-26
Primary completion
2023-10-09
Completion
2023-10-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Filgotinib Small molecule 100 mg Oral
Subject Filgotinib Small molecule 200 mg Oral

Indications