A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT05479058
- Run by
- Lakefront Biotherapeutics NV
- People needed
- 22
- Starts
- 2022-07-26
- Expected to finish
- 2023-10-09
- Last updated by the study team
- 2024-10-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie — Nantes, France
- Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition — Pessac, France
- Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie — Pierre-Bénite, France
- Hôpital Pontchaillou — Rennes, France
- Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie — Saint-Etienne, France
- Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie — Vandœuvre-lès-Nancy, France
- DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend — Berlin, Germany
- Universitätsklinikum Schleswig-Holstein — Kiel, Germany
- EUGASTRO GmbH — Leipzig, Germany
- Klinikum Lüneburg — Lüneburg, Germany
- Gastroenterologische Gemeinschaftspraxis Minden — Minden, Germany
- Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet — Budapest, Hungary
- Bugát Pál Kórház — Gyöngyös, Hungary
- IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II — Castellana Grotte, Italy
- Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva — Catanzaro, Italy
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.