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
860 Peachwood Drive
Orange City, Florida 32763
1082
mi
from 02139
Orange City, FL
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
475
mi
from 02139
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...
1078
mi
from 02139
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...
1601
mi
from 02139
Houston, TX
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610 3rd St # 206
Macon, Georgia 31201
948
mi
from 02139
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...
2576
mi
from 02139
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,...
1182
mi
from 02139
Tampa, FL
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Annapolis, Maryland 21401
365
mi
from 02139
Annapolis, MD
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Arlington, Texas 76012
1563
mi
from 02139
Arlington, TX
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Austin, Texas 78746
1691
mi
from 02139
Austin, TX
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Beavercreek, Ohio 45440
698
mi
from 02139
Beavercreek, OH
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Bountiful, Utah 84010
2088
mi
from 02139
Bountiful, UT
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Chesterfield, Michigan 48098
613
mi
from 02139
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,...
845
mi
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Chicago, IL
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735
mi
from 02139
Cincinnati, OH
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Clayton, Victoria 3168
10513
mi
from 02139
Clayton,
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Columbia, Maryland 21045
369
mi
from 02139
Columbia, MD
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Doral, Florida 33166
1257
mi
from 02139
Doral, FL
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3650 Northwest 82nd Avenue
Doral, Florida 33166
1257
mi
from 02139
Doral, FL
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1665 43rd Street South
Fargo, North Dakota 58103
1297
mi
from 02139
Fargo, ND
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Germantown, Tennessee 38138
1123
mi
from 02139
Germantown, TN
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Houston, Texas 77030
1605
mi
from 02139
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...
1047
mi
from 02139
Iowa City, IA
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Lakewood Ranch, Florida 34211
1210
mi
from 02139
Lakewood Ranch, FL
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Lansdowne, Virginia 20176
?
mi
from 02139
Lansdowne, VA
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2089
mi
from 02139
Layton, UT
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Live Oak, Texas 78233
1749
mi
from 02139
Live Oak, TX
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527
mi
from 02139
Mentor, OH
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286 Westward Drive
Miami, Florida 33144
1256
mi
from 02139
Miami, FL
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1257
mi
from 02139
Miami, FL
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1256
mi
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Miami, FL
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Middleburg Heights, Ohio 44130
554
mi
from 02139
Middleburg Heights, OH
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Monroe, Louisiana 71201
1332
mi
from 02139
Monroe, LA
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Naples, Florida 34102
1273
mi
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Naples, FL
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941
mi
from 02139
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,...
1356
mi
from 02139
New Orleans, LA
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5430 Jimmy Carter Boulevard
Norcross, Georgia 30093
919
mi
from 02139
Norcross, GA
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Richardson, Texas 75082
1532
mi
from 02139
Richardson, TX
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Richmond, Virginia 23249
475
mi
from 02139
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...
1036
mi
from 02139
Saint Louis, MO
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San Antonio, Texas 78229
1763
mi
from 02139
San Antonio, TX
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1804 Northeast Interstate 410 Loop
San Marcos, Texas 78666
1756
mi
from 02139
San Marcos, TX
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Santa Clarita, California 91350
2592
mi
from 02139
Santa Clarita, CA
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Shreveport, Louisiana 71103
1411
mi
from 02139
Shreveport, LA
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Southlake, Texas 76092
1557
mi
from 02139
Southlake, TX
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Spring, Texas 77386
1590
mi
from 02139
Spring, TX
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1011 Reed Avenue
Wyomissing, Pennsylvania 19610
288
mi
from 02139
Wyomissing, PA
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Zephyrhills, Florida 33542
1157
mi
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Zephyrhills, FL
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