Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease



Status:Recruiting
Conditions:Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/15/2019
Start Date:April 6, 2017
End Date:April 2020
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

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A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

The primary objective of this study is to evaluate the efficacy of filgotinib as compared to
placebo in establishing combined fistula response at Week 24. Participants will have the
option to enter a separate long-term extension study if they meet eligibility requirements.


Key Inclusion Criteria:

- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
the date of screening visit

- Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months

- Has draining perianal fistulae as a complication of CD, confirmed by MRI at screening

- Previously demonstrated an inadequate clinical response, loss of response to, or
intolerance of at least 1 of the following agents (depending on current country
treatment recommendations/guidelines):

- Antibiotics AND/OR

- Immunomodulators AND/OR

- TNFα Antagonist

- Is willing and able to undergo MRI per protocol requirements

- Is willing and able to undergo flexible sigmoidoscopy per protocol requirements

Key Exclusion Criteria:

- Presence of current rectovaginal anovaginal or enterovesicular fistulae

- Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis,
fulminant colitis, or toxic mega-colon

- History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy,
or likely requirement for surgery during the study

- Use of any prohibited concomitant medications as described in the study protocol

- Active tuberculosis (TB) or history of latent TB that has not been treated

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
30
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323 East Chestnut Street
Louisville, Kentucky 40202
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701 West Morse Boulevard
Winter Park, Florida 32789
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Arlington, Texas 76012
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Bountiful, Utah 84010
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Columbia, Maryland 21045
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Fort Sam Houston, Texas 78234
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Garland, Texas 75044
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Germantown, Tennessee 38138
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Lansdowne Town Center, Virginia 20176
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Las Vegas, Nevada 89113
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Monroe, Louisiana 71201
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Naples, Florida 34102
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601 East Rollins Street
Orlando, Florida 32803
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3100 Duraleigh Road
Raleigh, North Carolina 27607
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Richmond, Virginia 23249
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San Antonio, Texas 78229
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1305 Wonder World Drive
San Marcos, Texas 78666
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Shreveport, Louisiana 71103
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Southlake, Texas 76092
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2 Tampa General Circle
Tampa, Florida 33606
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