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
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...
1718
mi
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Saint Louis, MO
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
2436
mi
from 98109
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...
2452
mi
from 98109
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...
1884
mi
from 98109
Houston, TX
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610 3rd St # 206
Macon, Georgia 31201
2252
mi
from 98109
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...
1077
mi
from 98109
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,...
2527
mi
from 98109
Tampa, FL
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Annapolis, Maryland 21401
2343
mi
from 98109
Annapolis, MD
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Arlington, Texas 76012
1670
mi
from 98109
Arlington, TX
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Austin, Texas 78746
1770
mi
from 98109
Austin, TX
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Beavercreek, Ohio 45440
1967
mi
from 98109
Beavercreek, OH
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Bountiful, Utah 84010
695
mi
from 98109
Bountiful, UT
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Chesterfield, Michigan 48098
1920
mi
from 98109
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,...
1732
mi
from 98109
Chicago, IL
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1966
mi
from 98109
Cincinnati, OH
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Clayton, Victoria 3168
8189
mi
from 98109
Clayton,
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Columbia, Maryland 21045
2319
mi
from 98109
Columbia, MD
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Doral, Florida 33166
2722
mi
from 98109
Doral, FL
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3650 Northwest 82nd Avenue
Doral, Florida 33166
2724
mi
from 98109
Doral, FL
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1665 43rd Street South
Fargo, North Dakota 58103
1191
mi
from 98109
Fargo, ND
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Germantown, Tennessee 38138
1877
mi
from 98109
Germantown, TN
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Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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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...
1557
mi
from 98109
Iowa City, IA
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Lakewood Ranch, Florida 34211
2551
mi
from 98109
Lakewood Ranch, FL
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Lansdowne, Virginia 20176
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from 98109
Lansdowne, VA
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681
mi
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Layton, UT
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Live Oak, Texas 78233
1785
mi
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Live Oak, TX
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2032
mi
from 98109
Mentor, OH
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286 Westward Drive
Miami, Florida 33144
2725
mi
from 98109
Miami, FL
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2732
mi
from 98109
Miami, FL
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2730
mi
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Miami, FL
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Middleburg Heights, Ohio 44130
2019
mi
from 98109
Middleburg Heights, OH
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Monroe, Louisiana 71201
1890
mi
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Monroe, LA
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Naples, Florida 34102
2643
mi
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Naples, FL
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1971
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,...
2099
mi
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New Orleans, LA
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5430 Jimmy Carter Boulevard
Norcross, Georgia 30093
2180
mi
from 98109
Norcross, GA
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860 Peachwood Drive
Orange City, Florida 32763
2526
mi
from 98109
Orange City, FL
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Richardson, Texas 75082
1675
mi
from 98109
Richardson, TX
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Richmond, Virginia 23249
2349
mi
from 98109
Richmond, VA
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San Antonio, Texas 78229
1787
mi
from 98109
San Antonio, TX
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1804 Northeast Interstate 410 Loop
San Marcos, Texas 78666
1784
mi
from 98109
San Marcos, TX
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Santa Clarita, California 91350
934
mi
from 98109
Santa Clarita, CA
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Shreveport, Louisiana 71103
1821
mi
from 98109
Shreveport, LA
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Southlake, Texas 76092
1659
mi
from 98109
Southlake, TX
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Spring, Texas 77386
1871
mi
from 98109
Spring, TX
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1011 Reed Avenue
Wyomissing, Pennsylvania 19610
2323
mi
from 98109
Wyomissing, PA
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Zephyrhills, Florida 33542
2525
mi
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Zephyrhills, FL
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