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
1011 Reed Avenue
Wyomissing, Pennsylvania 19610
2331
mi
from 91732
Wyomissing, PA
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
2340
mi
from 91732
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...
2104
mi
from 91732
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...
1352
mi
from 91732
Houston, TX
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610 3rd St # 206
Macon, Georgia 31201
1974
mi
from 91732
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...
117
mi
from 91732
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,...
2136
mi
from 91732
Tampa, FL
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Annapolis, Maryland 21401
2309
mi
from 91732
Annapolis, MD
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Arlington, Texas 76012
1207
mi
from 91732
Arlington, TX
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Austin, Texas 78746
1212
mi
from 91732
Austin, TX
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Beavercreek, Ohio 45440
1904
mi
from 91732
Beavercreek, OH
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Bountiful, Utah 84010
578
mi
from 91732
Bountiful, UT
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Chesterfield, Michigan 48098
1963
mi
from 91732
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,...
1730
mi
from 91732
Chicago, IL
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1879
mi
from 91732
Cincinnati, OH
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Clayton, Victoria 3168
7944
mi
from 91732
Clayton,
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Columbia, Maryland 21045
2289
mi
from 91732
Columbia, MD
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Doral, Florida 33166
2311
mi
from 91732
Doral, FL
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3650 Northwest 82nd Avenue
Doral, Florida 33166
2313
mi
from 91732
Doral, FL
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1665 43rd Street South
Fargo, North Dakota 58103
1412
mi
from 91732
Fargo, ND
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Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
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Houston, Texas 77030
1357
mi
from 91732
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...
1528
mi
from 91732
Iowa City, IA
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Lakewood Ranch, Florida 34211
2149
mi
from 91732
Lakewood Ranch, FL
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Lansdowne, Virginia 20176
?
mi
from 91732
Lansdowne, VA
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585
mi
from 91732
Layton, UT
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Live Oak, Texas 78233
1194
mi
from 91732
Live Oak, TX
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2051
mi
from 91732
Mentor, OH
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286 Westward Drive
Miami, Florida 33144
2315
mi
from 91732
Miami, FL
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2322
mi
from 91732
Miami, FL
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2321
mi
from 91732
Miami, FL
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Middleburg Heights, Ohio 44130
2025
mi
from 91732
Middleburg Heights, OH
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Monroe, Louisiana 71201
1495
mi
from 91732
Monroe, LA
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Naples, Florida 34102
2220
mi
from 91732
Naples, FL
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1762
mi
from 91732
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,...
1655
mi
from 91732
New Orleans, LA
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5430 Jimmy Carter Boulevard
Norcross, Georgia 30093
1927
mi
from 91732
Norcross, GA
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860 Peachwood Drive
Orange City, Florida 32763
2176
mi
from 91732
Orange City, FL
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Richardson, Texas 75082
1229
mi
from 91732
Richardson, TX
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Richmond, Virginia 23249
2265
mi
from 91732
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...
1569
mi
from 91732
Saint Louis, MO
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San Antonio, Texas 78229
1188
mi
from 91732
San Antonio, TX
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1804 Northeast Interstate 410 Loop
San Marcos, Texas 78666
1189
mi
from 91732
San Marcos, TX
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Santa Clarita, California 91350
38
mi
from 91732
Santa Clarita, CA
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Shreveport, Louisiana 71103
1401
mi
from 91732
Shreveport, LA
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Southlake, Texas 76092
1203
mi
from 91732
Southlake, TX
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Spring, Texas 77386
1348
mi
from 91732
Spring, TX
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Zephyrhills, Florida 33542
2145
mi
from 91732
Zephyrhills, FL
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