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

• Status: Active, not recruiting
• Trial end date: 2022-11-07
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; Golimumab

Criteria

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