Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)



Status:Recruiting
Conditions:Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/3/2019
Start Date:April 11, 2017
End Date:March 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 Small Bowel Crohn's Disease (SBCD)

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared
to placebo, in establishing clinical remission in participants with Crohn's disease involving
the small bowel. 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, nonlactating females, ages 18 to 75 years, inclusive based on
the date of screening visit

- Moderately or severely active CD

- Minimum duration of CD of at least 6 months

- Presence of diseased SB segments in at least 1 of the following segments: terminal
ileum, distal ileum, or jejunum

- Patients with additional colonic involvement of CD are permitted in study as long as
SBCD is present

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

- Corticosteroids

- Immunomodulators

- Tumor necrosis factor-alpha (TNFα) antagonists

- Vedolizumab

- Ustekinumab

- Willing and able to undergo magnetic resonance enterography (MRE) per protocol
requirements

Key Exclusion Criteria:

- Presence of symptomatic or clinically significant (eg, obstructive or symptomatic)
strictures or stenosis.

- Presence of fistulae

- Evidence of short bowel syndrome

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

- History of total colectomy, subtotal-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
28
sites
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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Arlington, TX
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Bountiful, Utah 84010
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Chesterfield, Michigan 48098
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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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Columbia, MD
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1665 43rd Street South
Fargo, North Dakota 58103
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Fargo, ND
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Fort Sam Houston, Texas 78234
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Germantown, Tennessee 38138
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Hagerstown, Maryland 21740
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Indianapolis, IN
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Innsbruck,
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Lansdowne, Virginia 20176
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Largo, FL
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Miami, FL
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Naples, Florida 34102
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Naples, FL
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Nashville, TN
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Orlando, FL
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Pensacola, FL
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3100 Duraleigh Road
Raleigh, North Carolina 27607
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Richardson, Texas 75082
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Richmond, Virginia 23249
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Richmond, VA
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San Antonio, Texas 78229
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San Antonio, TX
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1804 Northeast Interstate 410 Loop
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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