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COMPLETED

NCT04630028

PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2021-03-17

Completion Date

2025-06-05

Last Updated

2026-05-14

Healthy Volunteers

Conditions

Colitis, Ulcerative

Interventions

DRUG

Ustekinumab Dose Based on BSA and Body Weight

As per BSA and body weight Ustekinumab will be administered SC and IV.

DRUG

Matching Placebo

Placebo will be administered subcutaneously.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (58)

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

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

Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

Nyíregyháza, Hungary

Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum

Szeged, Hungary

Shamir Medical Center Assaf Harofeh

Be’er Ya‘aqov, Israel

Rambam Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Juntendo University Hospital

Bunkyō City, Japan

Gunma University Hospital

Gunma, Japan

Kindai University Nara Hospital

Ikoma, Japan

Kurume University Hospital

Kurume, Japan

Saitama Childrens Medical Center

Saitama Shi, Japan

Miyagi Children's Hospital

Sendai, Japan

National Center for Child Health and Development

Setagaya Ku, Japan

Jichi Medical University Hospital

Shimotsuke, Japan

Mie University Hospital

Tsu, Japan

Szpital im. M. Kopernika

Gdansk, Poland

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Poland

Korczowski Bartosz Gabinet Lekarski

Rzeszów, Poland

GASTROMED Sp. z o.o.

Torun, Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, Poland

Kazan State Medical University

Kazan', Russia

Russian National Research Medical University named after N.I.Pirogov

Moscow, Russia

FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences

Moscow, Russia

Privolzhsky Research Medical University of Ministry of Health of Russian Federation

Nizhny Novgorod, Russia

Saratov State Medical University

Saratov, Russia

Yaroslavl Regional Children's Clinical Hospital

Yaroslavl, Russia

Birmingham Children's Hospital

Birmingham, United Kingdom

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Royal London Hospital

London, United Kingdom