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

  • STATUS
    Recruiting
  • participants needed
    1320
  • sponsor
    Gilead Sciences
Updated on 8 May 2018
Footscray Hospital (3.5 mi away) Contact
corticosteroids
remission
ustekinumab
tumor necrosis factor
maintenance treatment
vedolizumab
tumor necrosis factor alpha
tumour necrosis

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 IdentifierNCT02914561
SponsorGilead Sciences
Last Modified on8 May 2018

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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