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

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Suryakanth Gurudu, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Suryakanth Gurudu, M.D.

Closed for enrollment

More information

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