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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03662542
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Janssen Research & Development, LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation	Janssen Research & Development, LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Brazil, Germany, Mexico, Poland, Russian Federation, Ukraine, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Colitis, Ulcerative
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Combination Therapy

Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.

Experimental: Monotherapy: Guselkumab

Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.

Active Comparator: Monotherapy: Golimumab

Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.

Interventions

Drug: - Guselkumab Dose 1

Guselkumab Dose 1 will be administered as IV infusion.

Drug: - Guselkumab Dose 2

Guselkumab Dose 2 will be administered as SC injection.

Drug: - Golimumab Dose 1

Golimumab Dose 1 will be administered as SC injection.

Drug: - Golimumab Dose 2

Golimumab Dose 2 will be administered as SC injection.

Drug: - Placebo

Placebo will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Southern Arizona VA Healthcare System, Tucson, Arizona

Status

Withdrawn

Address

Southern Arizona VA Healthcare System

Tucson, Arizona, 85723

Site Contact

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