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A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

NCT03596645•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis \[UC\]) OR required more than 3 courses of corticosteroids in the past year
•Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 \[endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist\], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (\>=2)
•If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Participants who receive parenteral nutrition are not permitted to enroll in the trial
•No history of latent or active tuberculosis prior to screening
•Must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before Week 0

Exclusion Criteria

•History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances
•History of malignancy or macrophage activation syndrome or hemophagocytic lymphohistiocytosis
•Have UC limited to the rectum only or to \<20 percent (%) of the colon
•Presence of a stoma
•Presence or history of a fistula
•Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information

Locations (58)

University of California San Francisco

San Francisco, California, United States

Children's Hospital Colorado and University of Colorado

Aurora, Colorado, United States

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Nemours DuPont Hospital for Children

Wilmington, Delaware, United States

Children's Center for Digestive Health Care

Atlanta, Georgia, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Medical Center

New York, New York, United States

GI For Kids

Knoxville, Tennessee, United States

Children's Medical Center of Dallas

Dallas, Texas, United States

Key Dates

Start Date

October 29, 2018

Primary Completion Date

November 21, 2023

Completion Date

February 20, 2027

Last Updated

March 19, 2026

Enrollment

ACTUAL participants

Conditions

Colitis, Ulcerative

Interventions

Golimumab

DRUG

Infliximab

DRUG

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

NCT05076175

Colitis, Ulcerative

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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: March 19, 2026Data 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.

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A Study to Assess the Efficacy and Safety of Golimumab in Pediatric 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

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