A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
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Keep this study
Lead
Janssen Research & Development, LLC
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
