Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:25 - 55
Updated:4/6/2019
Start Date:July 11, 2017
End Date:October 2024
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

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A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Ulcerative Colitis

The primary objective of this study is to evaluate the testicular safety of filgotinib in
adult males with moderately to severely active ulcerative colitis.


Key Inclusion Criteria:

- Male participants who are between the ages of 25 and 55 (inclusive) on the day of
signing informed consent

- Documented diagnosis of ulcerative colitis (UC) of at least 4 months AND with a
minimum disease extent of 15 cm from the anal verge. Documentation should include
endoscopic and histopathologic evidence of UC

- Have moderately to severely active UC

Key Exclusion Criteria:

- Previously documented problems with male reproductive health

- Prior diagnosis of male infertility

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

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

- Use of concomitant prohibited medications as outlined by protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
48
sites
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Mentor, OH
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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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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Houston, TX
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610 3rd St # 206
Macon, Georgia 31201
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Macon, GA
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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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San Diego, CA
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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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Tampa, FL
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Annapolis, Maryland 21401
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Arlington, Texas 76012
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Arlington, TX
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Austin, Texas 78746
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Austin, TX
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Beavercreek, Ohio 45440
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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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Chicago, IL
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Cincinnati, OH
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Clayton, Victoria 3168
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Columbia, Maryland 21045
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Doral, Florida 33166
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3650 Northwest 82nd Avenue
Doral, Florida 33166
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Doral, FL
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1665 43rd Street South
Fargo, North Dakota 58103
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Fargo, ND
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Germantown, Tennessee 38138
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Germantown, TN
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Houston, Texas 77030
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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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Iowa City, IA
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Lakewood Ranch, Florida 34211
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Lansdowne, Virginia 20176
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Layton, UT
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Live Oak, Texas 78233
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286 Westward Drive
Miami, Florida 33144
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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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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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5430 Jimmy Carter Boulevard
Norcross, Georgia 30093
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860 Peachwood Drive
Orange City, Florida 32763
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Richardson, Texas 75082
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Richmond, Virginia 23249
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas 78229
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1804 Northeast Interstate 410 Loop
San Marcos, Texas 78666
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Santa Clarita, California 91350
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Shreveport, Louisiana 71103
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Southlake, Texas 76092
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Spring, Texas 77386
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1011 Reed Avenue
Wyomissing, Pennsylvania 19610
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Zephyrhills, Florida 33542
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