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NCT05923073PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

3/13/2024

Completion Date

7/12/2028

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

Age Range: 2 years to 17 years

Inclusion Criteria: * Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. * Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than or equal to \[\>=\] 30) * Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic 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 receiving study intervention at Week 0 * Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN) 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 require surgery. * Participants must not have an abscess * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline

Interventions

DRUG

Guselkumab

DRUG

Guselkumab

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Conditions

Crohn's Disease

Locations

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Connecticut Children's Medical Center

Hartford, Connecticut 06106

United States

Emory University

Atlanta, Georgia 30322

United States

Children's Center for Digestive Health Care

Atlanta, Georgia 30342

United States

Riley Hospital for Children

Indianapolis, Indiana 46202-5225

United States

Boston Childrens Hospital

Boston, Massachusetts 02115

United States

Goryeb Children's Hospital

Morristown, New Jersey 07960

United States

Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center

New York, New York 10021-5663

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Columbia University Medical Center

New York, New York 10032

United States

The Children's Medical Center of Dayton

Dayton, Ohio 45404

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Cook Childrens Medical Center

Fort Worth, Texas 76104

United States

University of Vermont Medical Center

Colchester, Vermont 05446

United States

Perth Children's Hospital

Nedlands, 6009

Australia

Mater Hospital Brisbane

South Brisbane, 4101

Australia

The Children's Hospital at Westmead

Westmead, 2145

Australia

AKH - Medizinische Universitat Wien

Vienna, 1090

Austria

Universitair Ziekenhuis Brussel

Brussels, 1090

Belgium

Cliniques Universitaires Saint Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, 13060-904

Brazil

Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro

Curitiba, 80250-060

Brazil

Universidade Federal de Goias - Hospital das Clinicas da UFG

Goiânia, 74605-020

Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, 90035-007

Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90035-074

Brazil

Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas

Vitória, 29040-091

Brazil

INTEGRAL Pesquisa e Ensino

Votuporanga, 100000

Brazil

Iwk Health Centre

Halifax, Nova Scotia B3K 6R8

Canada

London Health Sciences Centre Victoria Hospital

London, Ontario N6A 5W9

Canada

Hospital For Sick Children

Toronto, Ontario M5G 1X8

Canada

CHU Amiens-Hopital Nord

Amiens, 80054

France

Hôpital Jeanne de FLANDRE, CHRU LILLE

Lille, 59037

France

Hôpital Necker - Enfants Malades

Paris, 75015

France

Hôpital Robert Debré

Paris, 75019

France

Soroka University Medical Center

Beersheba, 84101

Israel

Shamir Medical Center Assaf Harofeh

Be’er Ya‘aqov, 70300

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Hadassah Medical Center

Jerusalem, 9124001

Israel

Schneider Children's Medical Center

Petah Tikva, 4920235

Israel

Kaplan Medical Center

Rehovot, 761001

Israel

A.O. Santi Antonio e Biagio e Cesare Arrigo

Alessandria, 15121

Italy

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

Bergamo, 24127

Italy

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

Bologna, 40124

Italy

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

Florence, 50139

Italy

Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi

Milan, 20154

Italy

AOU Policlinico Umberto I

Roma, 161

Italy

Hirosaki University Hospital

Hirosaki, 036-8563

Japan

Kagoshima University Hospital

Kagoshima, 890-8544

Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, 277-0871

Japan

Kobe University Hospital

Kobe, 650 0017

Japan

Saga University Hospital

Saga, 849-8501

Japan

Miyagi Childrens Hospital

Sendai, 989-3126

Japan

National Center for Child Health and Development

Setagaya Ku, 157 8535

Japan

Juntendo University Hospital

Tokyo, 113-8431

Japan

Mie University Hospital

Tsu, 514 8507

Japan

Yamaguchi University Hospital

Ube, 755-8505

Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, 230-8765

Japan

Yokohama City University Medical Center

Yokohama, 232-0024

Japan

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

Akershus Universitetssykehus HF

Nordbyhagen, 1474

Norway

Oslo University Hospital

Oslo, 424

Norway

Universitetssykehuset Nord-Norge HF

Tromsø, 9038

Norway

St. Olavs Hospital

Trondheim, 7030

Norway

Korczowski Bartosz Gabinet Lekarski

Rzeszów, 35-302

Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04 501

Poland

Instytut Pomnik Centrum Zdrowia

Warsaw, 04 730

Poland

Hospital de Braga

Braga, 4710-243

Portugal

Centro Hospitalar de Lisboa Norte Hospital Santa Maria

Lisbon, 1649-035

Portugal

Centro Hospitalar de Sao Joao E.P.E.

Porto, 4200-319

Portugal

Inje University Haeundae Paik Hospital

Busan, 48108

South Korea

Kyungpook National University Chilgok Hospital

Daegu, 41404

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Severance Hospital Yonsei University Health System

Seoul, 120-752

South Korea

Hosp Reina Sofia

Córdoba, 14004

Spain

Corporacio Sanitari Parc Tauli

Sabadell, 8208

Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026

Spain

Royal Hospital for Sick Children

Glasgow, G51 4TF

United Kingdom

Great Ormond Street Hospital

London, WC1N 3JH

United Kingdom

Nowgen Centre, Research and Innovation

Manchester, M13 9WL

United Kingdom

Royal Manchester Children's Hospital

Manchester, M13 9WL

United Kingdom

John Radcliffe Hospital

Oxford, OX3 9DU

United Kingdom

Sheffield Children's Hospital

Sheffield, S10 2TH

United Kingdom