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A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03662542•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (82)

Precision Research Institute

San Diego, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

GCP Clinical Research

Tampa, Florida, United States

Gastrointestinal Specialists of Georgia

Marietta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Woodholme Gastroenterology

Glen Burnie, Maryland, United States

Sierra Clinical Research

Las Vegas, Nevada, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Fargo Gastroenterology Clinic, PC

Fargo, North Dakota, United States

Key Dates

Start Date

November 20, 2018

Primary Completion Date

December 1, 2020

Completion Date

November 15, 2021

Last Updated

December 12, 2023

Enrollment

214

ACTUAL participants

Conditions

Colitis, Ulcerative

Interventions

Guselkumab Dose 1

DRUG

Guselkumab Dose 2

DRUG

Golimumab Dose 1

DRUG

Golimumab Dose 2

DRUG

Placebo

DRUG

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

NCT05076175

Colitis, Ulcerative

View study

RECRUITINGPHASE3

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

NCT06651281

Crohn DiseaseColitis, Ulcerative

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Diet Intervention Treatment for Active Ulcerative Colitis

Therapeutic Endpoint in Pediatric IBD Conditions

Texture and Color Enhancement Imaging (TXI) for Inflammation Assessment in Patients With Inflammatory Bowel Diseases

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis