Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

Phase 2 Completed 57 enrolled Gilead Sciences Lakefront Biotherapeutics NV · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.

Timeline

Start: 2017-04-06
Primary completion: 2021-01-20
Completion: 2021-02-17

Outcome

Missed primary endpoint

registry analysis (superiority test); Filgotinib 200 mg vs Placebo; Risk Difference in Percentages 22.1 (90% CI -9.9 to 50.0) NCT03077412 ↗

Publications

Reinisch W, Colombel JF, D'Haens GR, Rimola J, Masior T, McKevitt M, Ren X, Serone A, Schwartz DA, Gecse KB. Efficacy and Safety of Filgotinib for the Treatment of Perianal Fistulising Crohn's Disease [DIVERGENCE 2]: A Phase 2, Randomised, Placebo-controlled Trial. J Crohns Colitis. 2024 Jun 3;18(6):864-874. doi: 10.1093/ecco-jcc/jjae003.

Drugs

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