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, 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.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01555437` - Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)	N/A
	Recruiting	`NCT03646708` - Response Assessment in SB CD

NCT number	NCT03046056
Study type	Interventional
Source	Gilead Sciences
Contact
Status	Completed
Phase	Phase 2
Start date	April 11, 2017
Completion date	July 20, 2020

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) — DIVERGENCE 1

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms