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
Annapolis, Maryland 21401
354
mi
from 43215
Annapolis, MD
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
429
mi
from 43215
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...
714
mi
from 43215
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...
990
mi
from 43215
Houston, TX
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610 3rd St # 206
Macon, Georgia 31201
493
mi
from 43215
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...
1951
mi
from 43215
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,...
831
mi
from 43215
Tampa, FL
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Arlington, Texas 76012
927
mi
from 43215
Arlington, TX
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Austin, Texas 78746
1065
mi
from 43215
Austin, TX
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Beavercreek, Ohio 45440
57
mi
from 43215
Beavercreek, OH
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Bountiful, Utah 84010
1512
mi
from 43215
Bountiful, UT
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Chesterfield, Michigan 48098
182
mi
from 43215
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,...
274
mi
from 43215
Chicago, IL
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98
mi
from 43215
Cincinnati, OH
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Clayton, Victoria 3168
9876
mi
from 43215
Clayton,
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Columbia, Maryland 21045
332
mi
from 43215
Columbia, MD
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Doral, Florida 33166
989
mi
from 43215
Doral, FL
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3650 Northwest 82nd Avenue
Doral, Florida 33166
990
mi
from 43215
Doral, FL
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1665 43rd Street South
Fargo, North Dakota 58103
839
mi
from 43215
Fargo, ND
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Germantown, Tennessee 38138
501
mi
from 43215
Germantown, TN
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Houston, Texas 77030
995
mi
from 43215
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...
460
mi
from 43215
Iowa City, IA
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Lakewood Ranch, Florida 34211
864
mi
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Lakewood Ranch, FL
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Lansdowne, Virginia 20176
?
mi
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Lansdowne, VA
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1516
mi
from 43215
Layton, UT
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Live Oak, Texas 78233
1124
mi
from 43215
Live Oak, TX
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146
mi
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Mentor, OH
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286 Westward Drive
Miami, Florida 33144
989
mi
from 43215
Miami, FL
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994
mi
from 43215
Miami, FL
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992
mi
from 43215
Miami, FL
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Middleburg Heights, Ohio 44130
116
mi
from 43215
Middleburg Heights, OH
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Monroe, Louisiana 71201
720
mi
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Monroe, LA
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Naples, Florida 34102
957
mi
from 43215
Naples, FL
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334
mi
from 43215
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,...
797
mi
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New Orleans, LA
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5430 Jimmy Carter Boulevard
Norcross, Georgia 30093
423
mi
from 43215
Norcross, GA
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860 Peachwood Drive
Orange City, Florida 32763
760
mi
from 43215
Orange City, FL
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Richardson, Texas 75082
895
mi
from 43215
Richardson, TX
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Richmond, Virginia 23249
342
mi
from 43215
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...
397
mi
from 43215
Saint Louis, MO
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San Antonio, Texas 78229
1138
mi
from 43215
San Antonio, TX
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1804 Northeast Interstate 410 Loop
San Marcos, Texas 78666
1131
mi
from 43215
San Marcos, TX
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Santa Clarita, California 91350
1979
mi
from 43215
Santa Clarita, CA
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Shreveport, Louisiana 71103
789
mi
from 43215
Shreveport, LA
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Southlake, Texas 76092
920
mi
from 43215
Southlake, TX
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Spring, Texas 77386
976
mi
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Spring, TX
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1011 Reed Avenue
Wyomissing, Pennsylvania 19610
373
mi
from 43215
Wyomissing, PA
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Zephyrhills, Florida 33542
812
mi
from 43215
Zephyrhills, FL
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