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

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Recruiting
participants needed

1320
sponsor

Gilead Sciences

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Updated on 8 May 2018

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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 (Gilead Study GS-US-419-3896).

Details

Condition	Crohn's Disease
Treatment	Filgotinib, Placebo to match filgotinib
Clinical Study Identifier	NCT02914561
Sponsor	Gilead Sciences
Last Modified on	8 May 2018

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
	Documented diagnosis of CD with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
	Moderately to severely active CD
	Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents: corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
Exclusion Criteria
	Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae, short bowel syndrome, etc
	Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
	Active tuberculosis (TB) or history of latent TB that has not been treated
	Use of any prohibited concomitant medications as described in the study protocol
	NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply

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