A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Last updated: March 27, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Guselkumab

Guselkumab Subcutaneous

Guselkumab Intravenous

Clinical Study ID

NCT06260163
CR109251
CNTO1959PUC3001
2022-502238-22-00
2022-001285-35
  • Ages 2-17
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent forscreening

  • A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) mustbe available in the source documents. There is no maximum duration for which aparticipant needs to be diagnosed with UC. If the pathology report to support adocumented diagnosis of UC is not available in the source documents, the screeningendoscopy with biopsies (obtained within 3 weeks before first study interventionadministration) needs to support the diagnosis of UC.

  • Moderately to severely active UC, defined by a baseline modified Mayo (withoutphysician's global assessment) score of 5 through 9 inclusive, with a screening Mayoendoscopy subscore >= 2 as determined by a central review of the video of theendoscopy

  • Medically stable based on physical examination, medical history, and vital signs,performed at screening. Any abnormalities must be consistent with the underlyingillness in the study population and this determination must be recorded in theparticipant's source documents and acknowledged by the investigator

  • Participants must have had an inadequate response and/or intolerance to biologictherapy and/or conventional therapies or be dependent upon corticosteroids

Exclusion

Exclusion Criteria:

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

  • Presence of a stoma

  • Has had any kind of bowel resection within 6 months or any other intra-abdominalsurgery within 3 months of baseline

  • Have severe colitis or have evidence of Crohn's Disease (CD)

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: Guselkumab
Phase: 3
Study Start date:
January 19, 2024
Estimated Completion Date:
August 14, 2028

Connect with a study center

  • Perth Children's Hospital

    Nedlands, 6009
    Australia

    Active - Recruiting

  • The Kids Research Institute Australia on behalf of the Centre for Child Health Research

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    South Brisbane, 4101
    Australia

    Active - Recruiting

  • The Children's Hospital at Westmead

    Westmead, 2145
    Australia

    Active - Recruiting

  • CHU Charleroi Chimay

    Charleroi, 6042
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • UZ Brussel

    Jette, 1090
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Capital Institute of Pediatrics

    Beijing, 100020
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • Changzhou No 2 Peoples Hospital

    Changzhou City, 213004
    China

    Active - Recruiting

  • Changzhou No.2 People's Hospital

    Changzhou City, 213004
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310016
    China

    Active - Recruiting

  • The Childrens Hospital Zhejiang University School Of Medicine

    Hangzhou, 310005
    China

    Active - Recruiting

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Active - Recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Active - Recruiting

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004
    China

    Active - Recruiting

  • Henan Children's Hospital, Zhengzhou Children's Hospital

    ZhengZhou, 450018
    China

    Active - Recruiting

  • Aarhus Universitetshospital

    Aarhus N, 8200
    Denmark

    Active - Recruiting

  • Hvidovre Hospital

    Hvidovre, 2650
    Denmark

    Active - Recruiting

  • Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant

    Bron cedex, 69677
    France

    Active - Recruiting

  • Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant

    Bron cedex, 69677
    France

    Active - Recruiting

  • Hopital Francois Mitterand

    Dijon, 21000
    France

    Active - Recruiting

  • CHRU Lille

    Lille Cedex, 59037
    France

    Active - Recruiting

  • APHP Hopital Robert Debre

    Paris, 75019
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna, 40133
    Italy

    Active - Recruiting

  • AOU Meyer

    Firenze, 50139
    Italy

    Active - Recruiting

  • Ospedale S. Spirito, Azienda Sanitaria Pescara

    Pescara, 65124
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Active - Recruiting

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Active - Recruiting

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste, 34137
    Italy

    Active - Recruiting

  • Tokyo Metropolitan Children's Medical Center

    Fuchu, 183 8561
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, 920 8641
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe, 650 0017
    Japan

    Active - Recruiting

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861 8520
    Japan

    Active - Recruiting

  • Shinshu University Hospital

    Matsumoto, 390 8621
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Active - Recruiting

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku, 160-0023
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686
    Japan

    Active - Recruiting

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, 230-8765
    Japan

    Active - Recruiting

  • Akershus Universitetssykehus

    Lørenskog, 1478
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo, 0450
    Norway

    Active - Recruiting

  • Universitetssykehuset Nord-Norge HF

    Tromso, 9030
    Norway

    Active - Recruiting

  • St. Olavs Hospital

    Trondheim, 7030
    Norway

    Active - Recruiting

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Active - Recruiting

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warszawa, 04 730
    Poland

    Active - Recruiting

  • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 04 501
    Poland

    Active - Recruiting

  • Chln - Hosp. Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Uls Santa Maria - Hosp. Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Chp - Centro Materno Infantil Do Norte

    Porto, 4050-651
    Portugal

    Active - Recruiting

  • Chsj - Hosp. Sao Joao

    Porto, 4200 319
    Portugal

    Active - Recruiting

  • Uls Santo Antonio - Cmin

    Porto, 4050-651
    Portugal

    Active - Recruiting

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319
    Portugal

    Active - Recruiting

  • Hosp. Infantil Univ. Nino Jesus

    Madrid, 28009
    Spain

    Active - Recruiting

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Hosp. Univ. I Politecni La Fe

    València, 46026
    Spain

    Active - Recruiting

  • Ankara University Medical Faculty

    Ankara, 6620
    Turkey

    Active - Recruiting

  • Gazi University Medical Faculty

    Ankara, 06560
    Turkey

    Active - Recruiting

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Marmara University Pendik Training Hospital

    Istanbul, 34899
    Turkey

    Active - Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • NYU Langone Health

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • NYU Langone Long Island Clinical Research Associates

    Lake Success, New York 11042
    United States

    Active - Recruiting

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