A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn's Disease

About this Study

Crohn's disease (CD) is a relapsing and remitting form of inflammatory bowel disease (IBD) that causes gastrointestinal signs and symptoms of diarrhea, abdominal pain, weight loss, and the passage of blood or mucous per rectum. The inflammation of CD can involve the mucosal surface of the gastrointestinal tract and penetrate through the full thickness of the gastrointestinal
wall, including the serosal surface. A need for safer, better tolerated, durable efficacious therapies for patients with CD exists. Despite significant uptake in the use of anti-TNF agents, tolerability of anti-TNFs due to allergic and autoimmune reactions, lack of durable response, and significant increased risk of infection remain problematic. Filgotinib is a once daily, oral therapy that may prove efficacious without the risk of allergic and autoimmune phenomena observed with anti-TNF agents.This is a long-term extension study to provide treatment with filgotinib for subjects with moderately to severely active CD (who have completed or met protocol specified efficacy
discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for CD) for
144 weeks.

Sponsor Protocol ID:GS-US-419-3896
IRB Number:2019-0309
Actively Enrolling
Early Phase 1
January 08, 2020
Eligibility Criteria
Both Male and Female

Inclusion Criteria1) Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial

 2) Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment

3) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 6, for the duration described

4) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug 

Exclusion Criteria1) Subjects who are discontinued from a parent study for reasons other than disease worsening or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for this study

2) Known hypersensitivity to the study drug 

3) Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol

4) Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 35 days of the last dose of the study drug 

5) Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug 

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Digestive Conditions
Participating Locations
Belhaven - University Physicians
University Hospital
Contact Information
Contact Name: Olivia Henry
Phone Number: 601-984-4540
Email: ohenry@umc.edu
Principal Investigator:Glover, Sarah C, D.O.
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