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
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...
429
mi
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Iowa City, IA
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
1186
mi
from
Chesapeake, VA
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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...
1049
mi
from
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...
563
mi
from
Houston, TX
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610 3rd St # 206
Macon, Georgia 31201
868
mi
from
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...
1142
mi
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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,...
1117
mi
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Tampa, FL
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Annapolis, Maryland 21401
1155
mi
from
Annapolis, MD
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Arlington, Texas 76012
348
mi
from
Arlington, TX
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Austin, Texas 78746
517
mi
from
Austin, TX
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Beavercreek, Ohio 45440
753
mi
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Beavercreek, OH
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Bountiful, Utah 84010
781
mi
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Bountiful, UT
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Chesterfield, Michigan 48098
842
mi
from
Chesterfield, MI
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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,...
611
mi
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Chicago, IL
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725
mi
from
Cincinnati, OH
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Clayton, Victoria 3168
9071
mi
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Clayton,
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Columbia, Maryland 21045
1136
mi
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Columbia, MD
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Doral, Florida 33166
1311
mi
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Doral, FL
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3650 Northwest 82nd Avenue
Doral, Florida 33166
1313
mi
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Doral, FL
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1665 43rd Street South
Fargo, North Dakota 58103
631
mi
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Fargo, ND
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Germantown, Tennessee 38138
481
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Germantown, TN
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Houston, Texas 77030
572
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Houston, TX
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Lakewood Ranch, Florida 34211
1140
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Lakewood Ranch, FL
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Lansdowne, Virginia 20176
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Lansdowne, VA
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789
mi
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Layton, UT
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Live Oak, Texas 78233
566
mi
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Live Oak, TX
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915
mi
from
Mentor, OH
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286 Westward Drive
Miami, Florida 33144
1315
mi
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Miami, FL
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1322
mi
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Miami, FL
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1320
mi
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Miami, FL
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Middleburg Heights, Ohio 44130
887
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Middleburg Heights, OH
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Monroe, Louisiana 71201
484
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Monroe, LA
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Naples, Florida 34102
1231
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Naples, FL
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618
mi
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Nashville, TN
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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,...
697
mi
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New Orleans, LA
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5430 Jimmy Carter Boulevard
Norcross, Georgia 30093
806
mi
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Norcross, GA
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860 Peachwood Drive
Orange City, Florida 32763
1123
mi
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Orange City, FL
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Richardson, Texas 75082
334
mi
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Richardson, TX
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Richmond, Virginia 23249
1110
mi
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Richmond, VA
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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...
414
mi
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Saint Louis, MO
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San Antonio, Texas 78229
576
mi
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San Antonio, TX
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1804 Northeast Interstate 410 Loop
San Marcos, Texas 78666
570
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San Marcos, TX
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Santa Clarita, California 91350
1177
mi
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Santa Clarita, CA
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Shreveport, Louisiana 71103
429
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Shreveport, LA
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Southlake, Texas 76092
334
mi
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Southlake, TX
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Spring, Texas 77386
547
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Spring, TX
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1011 Reed Avenue
Wyomissing, Pennsylvania 19610
1183
mi
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Wyomissing, PA
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Zephyrhills, Florida 33542
1117
mi
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Zephyrhills, FL
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