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

Last updated: July 17, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Matching Placebo

Ustekinumab Dose Based on BSA and Body Weight

Clinical Study ID

NCT04630028
CR108865
CNTO1275PUC3001
2019-004224-38
2023-504977-19-00
  • Ages 2-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medically stable on the basis of physical examination, medical history, and vitalsigns, performed at screening. Any abnormalities must be consistent with theunderlying illness in the study population and this determination must be recordedin 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 tothe left side of the colon for >= 10 years, must: a) have had a full colonoscopy toassess for the presence of dysplasia within 1 year before the first administrationof study intervention or b) have a full colonoscopy with surveillance for dysplasiaas the baseline endoscopy during the screening period. Results from thesesurveillance biopsies must be negative for dysplasia (low-grade, high-grade, orindeterminant) prior to the first administration of study intervention

  • Females of childbearing potential must have a negative highly sensitive urinepregnancy test at screening and at Week I-0 prior to study interventionadministration

Exclusion

Exclusion Criteria:

  • Have UC limited to the rectum only or to less than (<) 20 centimeter (cm) of thecolon

  • Presence or history of colonic or small bowel obstruction within 6 months prior toscreening, confirmed by objective radiographic or endoscopic evidence of a stricturewith resulting obstruction (dilation of the colon or small bowel proximal to thestricture on barium radiograph or an inability to traverse the stricture atendoscopy)

  • Have a history of latent or active granulomatous infection, histoplasmosis, orcoccidioidomycosis, or have had a nontuberculous mycobacterial infection prior toscreening

  • Presence or history of any malignancy including presence or history oflymphoproliferative disease including lymphoma, or signs and symptoms suggestive ofpossible lymphoproliferative disease, such as lymphadenopathy of unusual size orlocation (example, nodes in the posterior triangle of the neck, infraclavicular,epitrochlear, or periaortic areas) and monoclonal gammopathy of undeterminedsignificance, or clinically significant hepatomegaly or splenomegaly

  • Has known allergies, hypersensitivity, or intolerance to ustekinumab or itsexcipients

Study Design

Total Participants: 112
Treatment Group(s): 2
Primary Treatment: Matching Placebo
Phase: 3
Study Start date:
March 17, 2021
Estimated Completion Date:
June 05, 2025

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussel, 1200
    Belgium

    Site Not Available

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussel, 1020
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Brussel

    Jette, 1090
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Universitätsklinikum Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Charite-Universitätsmedizin Berlin - Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Erlangen

    Erlangen, 91054
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Universitatsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Site Not Available

  • Dr. von Haunersches Kinderspital

    Munich, 80337
    Germany

    Site Not Available

  • KUNO Klinik St. Hedwig

    Regensburg, 93049
    Germany

    Site Not Available

  • Universitatsklinikum Ulm

    Ulm, 89075
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89075
    Germany

    Completed

  • Semmelweis Egyetem

    Budapest, 1083
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526
    Hungary

    Site Not Available

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526
    Hungary

    Active - Recruiting

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526
    Hungary

    Site Not Available

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyiregyhaza, 4400
    Hungary

    Site Not Available

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz

    Nyiregyhaza, 4400
    Hungary

    Active - Recruiting

  • Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum

    Szeged, 6720
    Hungary

    Site Not Available

  • Shamir Medical Center Assaf Harofeh

    Be Er Ya Akov, 70300
    Israel

    Site Not Available

  • Shamir Medical Center (Assaf Harofeh)

    Be'er Ya'akov, 70300
    Israel

    Site Not Available

  • Carmel Medical Center

    Haifa, 3436212
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah Tikva, 4920235
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 30700
    Israel

    Site Not Available

  • Juntendo University Hospital

    Bunkyo Ku, 113 8431
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-Ku, 113-8431
    Japan

    Site Not Available

  • Kurume University Hospital

    Fukuoka, 830-0011
    Japan

    Site Not Available

  • Gunma University Hospital

    Gunma, 371-0034
    Japan

    Site Not Available

  • Kindai University Nara Hospital

    Ikoma, 630-0293
    Japan

    Site Not Available

  • Osaka Women's and Children's Hospital

    Izumi-shi, Osaka, 594-1101
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume, 830-0011
    Japan

    Site Not Available

  • Aichi Children's Health and Medical Center

    Obu, 474-0031
    Japan

    Site Not Available

  • Saitama Childrens Medical Center

    Saitama shi, 330-8777
    Japan

    Site Not Available

  • Saitama Children's Medical Center

    Saitama-shi, 330-8777
    Japan

    Site Not Available

  • Miyagi Children's Hospital

    Sendai, 989-3126
    Japan

    Site Not Available

  • Miyagi Children'S Hospital

    Sendai-shi, 989-3126
    Japan

    Site Not Available

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535
    Japan

    Site Not Available

  • National Center for Child Health and Development

    Setagaya-ku, 157-8535
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu, 514 8507
    Japan

    Site Not Available

  • Szpital im. M. Kopernika

    Gdansk, 80 803
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30 663
    Poland

    Site Not Available

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Active - Recruiting

  • GASTROMED Sp. z o.o.

    Torun, 87 100
    Poland

    Site Not Available

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    Warszawa, 04-730
    Poland

    Active - Recruiting

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warszawa, 04 730
    Poland

    Site Not Available

  • Medical Network

    Warszawa, 04-501
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 04 501
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-369
    Poland

    Site Not Available

  • Kazan State Medical University

    Kazan, 420138
    Russian Federation

    Site Not Available

  • Kemerovo Regional Clinical Hospital

    Kemerovo, 650066
    Russian Federation

    Site Not Available

  • Krasnoyarsk State Medical University

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

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

    Moscow, 119991
    Russian Federation

    Site Not Available

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

    Moscow, 119571
    Russian Federation

    Site Not Available

  • Privolzhsky Research Medical University of Ministry of Health of Russian Federation

    Nizhny Novgorod, 603950
    Russian Federation

    Site Not Available

  • Saratov State Medical University

    Saratov, 410054
    Russian Federation

    Site Not Available

  • Yaroslavl Regional Children's Clinical Hospital

    Yaroslavl, 150032
    Russian Federation

    Site Not Available

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Royal Hospital for Children and Young People

    Edinburgh, EH16 4TJ
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London, E1 2AT
    United Kingdom

    Site Not Available

  • Nemours DuPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Children's Center for Digestive Health Care

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Morristown Memorial Hospital

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Cohen Children's Medical Center

    Lake Success, New York 11042
    United States

    Site Not Available

  • Levine Children's at Atrium Health

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Levine Childrens at Atrium Health

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Center For Digestive Health Systems-Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Children's Medical Center of Dallas

    Dallas, Texas 75207
    United States

    Site Not Available

  • Cook Childrens Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Pediatric Specialists Of Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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