Study to Evaluate the Efficacy & Safety of Filgotinib in the Treatment of

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Completed	`NCT01624376` - Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease	Phase 2
Withdrawn	`NCT02677350` - AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE)	Phase 1
Completed	`NCT03452501` - Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients

NCT number	NCT03077412
Study type	Interventional
Source	Gilead Sciences
Contact
Status	Completed
Phase	Phase 2
Start date	April 6, 2017
Completion date	February 17, 2021

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease — Divergence2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms