A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Completed · Phase 3 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.

Key facts

Study ID

NCT04630028

Run by

Janssen Research & Development, LLC

People needed

112

Starts

2021-03-17

Expected to finish

2025-06-05

Last updated by the study team

2026-05-14

Who can join

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

You may qualify if…

• Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
• Must have had UC diagnosed prior to screening
• Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy
• A participant who has had extensive colitis for >= 8 years, or disease limited to the left side of the colon for >= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention
• Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration

You may not qualify if…

• Have UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
• Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy)
• Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening
• Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly
• Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients

Where it is running

• Children's Center for Digestive Health Care — Atlanta, Georgia, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Levine Childrens at Atrium Health — Charlotte, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
• Cook Childrens Medical Center — Fort Worth, Texas, United States
• Pediatric Specialists Of Virginia — Fairfax, Virginia, United States
• Universitair Kinderziekenhuis Koningin Fabiola — Brussels, Belgium
• Cliniques Universitaires Saint Luc — Brussels, Belgium
• UZ Gent — Ghent, Belgium
• UZ Brussel — Jette, Belgium
• UZ Leuven — Leuven, Belgium
• Universitätsklinikum Aachen — Aachen, Germany
• Charite-Universitätsmedizin Berlin - Berlin — Berlin, Germany
• Universitatsklinikum Erlangen — Erlangen, Germany
• Universitatsklinikum Essen — Essen, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Dr. von Haunersches Kinderspital — Munich, Germany
• KUNO Klinik St. Hedwig — Regensburg, Germany
• Universitatsklinikum Ulm — Ulm, Germany
• Semmelweis Egyetem — Budapest, Hungary
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
• Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz — Miskolc, Hungary
• Nemours DuPont Hospital for Children — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

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