A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

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

Phase

3

Condition

Ulcerative Colitis

Colic

Bowel Dysfunction

Treatment

Guselkumab

Placebo

Clinical Study ID

NCT05923073
CR109212
CNTO1959PBCRD3007
2023-504735-41-00
2021-006282-37
  • Ages 2-17
  • All Genders

Study Summary

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, withactive colitis, ileitis, or ileocolitis, confirmed at any time in the past byclinical, endoscopic, and histologic criteria.

  • Participants must have moderately to severely active CD (as defined by a baselinePediatric Crohn's Disease Activity Index [PCDAI] score greater than or equal to [>=]

  • Participants must have endoscopy with evidence of active CD defined as SimpleEndoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (>=) 6 (or >=4 for participants with isolated ileal disease) within 1 month of receivingstudy intervention at Week 0

  • Participants must have a prior or current CD medication history that includes eitherinadequate response, loss of response to or failure to tolerate current treatmentimmunomodulators or with oral or intravenously (IV) corticosteroids or have receivedbiologic therapy/JAK inhibitor for the treatment of CD and have a documented historyof inadequate response, loss of response (LOR), or intolerance to the biologictherapy/JAK inhibitor

Exclusion

Exclusion Criteria:

  • Participants has complications of CD such as symptomatic strictures or stenosis,short gut syndrome, or any other manifestation that might be anticipated to requiresurgery.

  • Participants must not have an abscess

  • Participants must not have any kind of bowel resection within 26 weeks or any otherintra-abdominal surgery within 12 weeks of baseline

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Guselkumab
Phase: 3
Study Start date:
March 13, 2024
Estimated Completion Date:
April 27, 2028

Connect with a study center

  • Perth Children's Hospital

    Nedlands, 6009
    Australia

    Site Not Available

  • Women's and Children's Hospital

    North Adelaide, 5006
    Australia

    Site Not Available

  • Mater Hospital Brisbane

    South Brisbane, 4101
    Australia

    Site Not Available

  • AKH - Medizinische Universitat Wien

    Vienna, 1090
    Austria

    Active - Recruiting

  • AKH - Medizinische Universität Wien

    Vienna, 1090
    Austria

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussel, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel

    Brussels, 1090
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro

    Campinas, 13060-904
    Brazil

    Site Not Available

  • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

    Campinas, 13060-904
    Brazil

    Active - Recruiting

  • Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro

    Curitiba, 80.250-060
    Brazil

    Active - Recruiting

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    Goiania, 74605-020
    Brazil

    Active - Recruiting

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    Goiânia, 74605-020
    Brazil

    Site Not Available

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035-074
    Brazil

    Active - Recruiting

  • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP

    Ribeirao Preto, 14098-900
    Brazil

    Site Not Available

  • Centro de Ciências e Saúde da Universidade Federal do Espirito Santo-Núcleo de Doenças Infecciosas

    Vitória, 29040-091
    Brazil

    Active - Recruiting

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 100000
    Brazil

    Active - Recruiting

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

  • Iwk Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Hospital For Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha 5, 150 06
    Czechia

    Site Not Available

  • CHU Amiens-Hopital Nord

    Amiens Cedex 1, 80054
    France

    Active - Recruiting

  • Hôpital Jeanne de FLANDRE, CHRU LILLE

    Lille, 59037
    France

    Active - Recruiting

  • Hôpital Robert Debré

    Paris, 75019
    France

    Active - Recruiting

  • Hôpital Necker - Enfants Malades

    Paris cedex 15, 75015
    France

    Active - Recruiting

  • Shamir Medical Center Assaf Harofeh

    Be Er Ya Akov, 70300
    Israel

    Active - Recruiting

  • Shamir Medical Center (Assaf Harofeh)

    Be'er Ya'akov, 70300
    Israel

    Site Not Available

  • Soroka University Medical Center

    Beersheba, 84101
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, 9124001
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petach-Tikva, 4920235
    Israel

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna

    Bologna, 40124
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Firenze, 50139
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi

    Milano, 20154
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, 161
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Site Not Available

  • Hirosaki University Hospital

    Hirosaki, 036-8563
    Japan

    Active - Recruiting

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, 277-0871
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Active - Recruiting

  • Miyagi Children's Hospital

    Sendai, 989-3126
    Japan

    Active - Recruiting

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama-shi, 232-0024
    Japan

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 120-752
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Akershus Universitetssykehus HF

    Nordbyhagen, 1474
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo, 424
    Norway

    Active - Recruiting

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9038
    Norway

    Active - Recruiting

  • St. Olavs Hospital

    Trondheim, 7030
    Norway

    Active - Recruiting

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30-663
    Poland

    Site Not Available

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Active - Recruiting

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Centrum Zdrowia MDM

    Warszawa, 00-635
    Poland

    Active - Recruiting

  • Instytut Pomnik Centrum Zdrowia

    Warszawa, 04 730
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 04 501
    Poland

    Active - Recruiting

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Norte Hospital Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Sao Joao E.P.E.

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • Centro Hospitalar de São João, E.P.E.

    Porto, 4200-319
    Portugal

    Site Not Available

  • Hosp Reina Sofia

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hosp. Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Hosp. Infantil Univ. Niño Jesus

    Madrid, 28009
    Spain

    Site Not Available

  • Hosp. Univ. de La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Corporacio Sanitari Parc Tauli

    Sabadell, 8208
    Spain

    Active - Recruiting

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • INSELSPITAL, Universitätsspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Kinderspital Zürich

    Zürich, 8032
    Switzerland

    Site Not Available

  • King's College Hospital

    Denmark Hill, SE5 9RS
    United Kingdom

    Site Not Available

  • Royal Hospital for Sick Children

    Glasgow, G51 4TF
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Nowgen Centre, Research and Innovation

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • John Radcliffe Hospital

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield, S1 0 2TH
    United Kingdom

    Active - Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arkansas Childrens Hospital Research Institute

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Children's Center for Digestive Health Care

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana 46202-5225
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • The Retina Inst. William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center

    New York, New York 10021-5663
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Palmetto Pediatric Gastroenterology & Nutrition

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • East Tennessee Children's Hospital

    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • Cook Childrens Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Vermont Medical Center

    Colchester, Vermont 05446
    United States

    Active - Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226-4874
    United States

    Site Not Available

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