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 |
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).
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
sites
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
Chesapeake, Virginia 23320
757-547-0798
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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