Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

Summary

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

Timeline

Start

2016-10-31

Primary completion

2022-11-11

Completion

2022-11-11

Outcome

Mixed primary results

paper INTERPRETATION: Filgotinib 200 mg did not meet the co-primary endpoints of clinical remission and an endoscopic response at week 10, PMID 39637881 ↗

paper but did meet the co-primary endpoints at week 58. PMID 39637881 ↗

paper Co-primary endpoints were not met for filgotinib 100 mg in any study. PMID 39637881 ↗

Publications

• Vermeire S, Schreiber S, Rubin DT, D'Haens G, Reinisch W, Watanabe M, Mehta R, Roblin X, Beales I, Gietka P, Hibi T, Hospodarskyy I, Ritter T, Genovese MC, Kwon P, Santermans E, Le Brun FO, Barron R, Masior T, Danese S. Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Feb;10(2):138-153. doi: 10.1016/S2468-1253(24)00272-3. Epub 2024 Dec 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filgotinib	Small molecule	100 mg	Oral
Subject	Filgotinib	Small molecule	200 mg	Oral

Indications