A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:3/27/2019
Start Date:November 20, 2018
End Date:August 11, 2021
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the clinical efficacy and safety of combination
therapy with guselkumab and golimumab in participants with moderately to severely active
ulcerative colitis (UC).


Inclusion Criteria:

- Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before
screening

- Moderately to severely active UC as defined by Mayo score

- History of inadequate response to or failure to tolerate conventional therapy

- Has screening laboratory test results within the study protocol defined parameters

- A woman of childbearing potential must have a negative highly sensitive serum (beta
human chorionic gonadotropin) pregnancy test result at screening and a negative urine
pregnancy test result at Week 0

Exclusion Criteria:

- Has severe extensive colitis as defined in the study protocol

- Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon

- Has a history of latent or active granulomatous infection, including histoplasmosis or
coccidioidomycosis, before screening

- Has any known malignancy or has a history of malignancy (with the exception of basal
cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in
situ that has been treated with no evidence of recurrence; or squamous cell carcinoma
of the skin that has been treated with no evidence of recurrence within 5 years before
screening)

- Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or
their excipients
We found this trial at
17
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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Chevy Chase, Maryland 20815
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Colorado Springs, Colorado 80907
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Detroit, Michigan 48201
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Fargo, North Dakota 58103
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Marietta, Georgia 30060
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San Diego, California 92115
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Tacoma, Washington 98405
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4710 North Habana Avenue
Tampa, Florida 33614
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