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



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/10/2019
Start Date:October 31, 2016
End Date:December 2019
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

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Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease

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).


Key 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 3 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 (depending on current country
treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor
necrosis factor alpha (TNFa) antagonists, or vedolizumab

Key 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.
We found this trial at
94
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26103 Interstate 45
The Woodlands, Texas 77380
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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610 3rd St # 206
Macon, Georgia 31201
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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701 West Morse Boulevard
Winter Park, Florida 32789
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Annapolis, Maryland 21401
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Arlington, Texas 76012
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Austin, Texas 78745
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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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Baytown, Texas 77512
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Bountiful, Utah 84010
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2001 Oriental Boulevard
Brooklyn, New York 11235
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Charlotte, North Carolina 28207
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, Virginia 22911
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6035 Shallowford Road
Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48098
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
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222 Piedmont Avenue
Cincinnati, Ohio 45229
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Columbia, Maryland 21045
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Corona, California 92881
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Egg Harbor Township, New Jersey 08234
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1665 43rd Street South
Fargo, North Dakota 58103
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Farmington, Connecticut 06032
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Fort Sam Houston, Texas 78234
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Gainesville, Florida 32610
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Germantown, Tennessee 38138
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Great Neck, New York 11021
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Hagerstown, Maryland 21740
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Houston, Texas 77025
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Houston, Texas 77004
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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425 Volker Boulevard
Kansas City, Missouri 64131
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La Jolla, California 92093
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Lakewood Ranch, Florida 34211
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Las Vegas, Nevada 89113
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Leesburg, Virginia 20176
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Lone Tree, Colorado
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323 East Chestnut Street
Louisville, Kentucky 40202
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
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Marietta, Georgia 30060
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Miami, Florida 33175
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Miami Springs, Florida 33166
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Middleburg Heights, Ohio 44130
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Monroe, Louisiana 71201
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Naples, Florida 34102
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Nashville, Tennessee 37211
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New Orleans, Louisiana 70121
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Norfolk, Virginia 23502
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Orangeburg, South Carolina 29118
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601 East Rollins Street
Orlando, Florida 32803
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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3100 Duraleigh Road
Raleigh, North Carolina 27607
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Richardson, Texas 75082
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, Virginia 23249
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Rochester, Minnesota 55905
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#65 - 25 Carrera 54
Rosario, 111221
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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San Antonio, Texas 78229
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San Antonio, Texas 78265
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1305 Wonder World Drive
San Marcos, Texas 78666
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Santa Clarita, California 91350
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
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Shreveport, Louisiana 71103
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Southlake, Texas 76092
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Troy, Michigan 48098
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Tulsa, Oklahoma 74137
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
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Zephyrhills, Florida 33542
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