Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis



Status:Active, not recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/27/2019
Start Date:November 14, 2016
End Date:December 2019

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Combined Phase 2b/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 Ulcerative Colitis

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in
the induction and maintenance treatment of moderately to severely active ulcerative colitis
(UC) 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-418-3899).


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 UC of at least 6 months AND with a minimum disease extent of
15 cm from the anal verge. Documentation should include endoscopic and histopathologic
evidence of UC.

- A surveillance colonoscopy is required at screening in individuals with a history of
UC for 8 or more years, if one was not performed in the prior 24 months

- Moderately to severely active UC

- 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:

- Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant
colitis, ulcerative proctitis, or toxic mega-colon

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

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
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Columbia, Maryland 21045
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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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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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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
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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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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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Hagerstown, Maryland 21740
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Houston, Texas 77025
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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425 Volker Boulevard
Kansas City, Missouri 64131
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9500 Gilman Drive
La Jolla, California 92093
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Lakewood Ranch, Florida 34211
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Lansdowne, Virginia 20176
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Long Beach, California 90822
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323 East Chestnut Street
Louisville, Kentucky 40202
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750 Highland Avenue
Madison, Wisconsin 03705
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Middleburg Heights, Ohio 44130
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Monroe, Louisiana 71201
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3100 Duraleigh Road
Raleigh, North Carolina 27607
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Rapid City, South Dakota 57701
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Richardson, Texas 75082
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Richmond, Virginia 23298
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Richmond, Virginia 23249
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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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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26103 Interstate 45
The Woodlands, Texas 77380
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