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

Running, not enrolling · Phase 3

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT03596645

Run by

Janssen Research & Development, LLC

People needed

84

Starts

2018-10-29

Expected to finish

2027-02-01

Last updated by the study team

2026-07-06

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Cook Childrens Medical Center — Fort Worth, Texas, United States
• DHAT Research Institute — Garland, Texas, United States
• Universitair Kinderziekenhuis Koningin Fabiola — Brussels, Belgium
• Cliniques Universitaires Saint Luc — Brussels, Belgium
• UZ Brussel — Jette, Belgium
• MK Blumenau Pesquisa Clínica — Blumenau, Brazil
• Hospital Pequeno Principe — Curitiba, Brazil
• Irmandade Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Brazil
• BR Trials — São Paulo, Brazil
• Hopital Pellegrin CHU Bordeaux — Bordeaux, France
• Hôpital Necker — Paris, France
• Rambam Medical Center — Haifa, Israel
• Shaare Zedek Medical Center — Jerusalem, Israel
• Schneider Children's Medical Center — Petah Tikva, Israel
• Sheba Medical Center — Ramat Gan, Israel
• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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