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) |
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.
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
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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112 Gainsborough Square
Chesapeake, Virginia 23320
Chesapeake, Virginia 23320
757-547-0798
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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1580 Antelope Drive
Layton, Utah 84041
Layton, Utah 84041
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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