Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

Phase 2 Completed 78 enrolled Gilead Sciences Lakefront Biotherapeutics NV · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Timeline

Start: 2017-04-11
Primary completion: 2020-07-20
Completion: 2020-07-20

Outcome

Missed primary endpoint

registry analysis (superiority test); Filgotinib 200 mg vs Placebo; Risk Difference in Proportions 8.3 (90% CI -16.5 to 32.1) NCT03046056 ↗

registry analysis (superiority test); Filgotinib 100 mg vs Placebo; Risk Difference in Proportions 8.3 (90% CI -15.9 to 32.0) NCT03046056 ↗

Publications

Riviere P, D'Haens G, Peyrin-Biroulet L, Baert F, Lambrecht G, Pariente B, Bossuyt P, Buisson A, Oldenburg B, Vermeire S, Laharie D. Location but Not Severity of Endoscopic Lesions Influences Endoscopic Remission Rates in Crohn's Disease: A Post Hoc Analysis of TAILORIX. Am J Gastroenterol. 2021 Jan 1;116(1):134-141. doi: 10.14309/ajg.0000000000000834.

Drugs

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