RecruitingPhase 3NCT05923073

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

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease

Sponsor

Janssen Research & Development, LLC

Enrollment

120 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Crohn's Disease

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

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called guselkumab — an antibody that blocks a specific inflammatory protein called IL-23 — in children with moderate to severe Crohn's disease, a chronic inflammatory bowel condition that causes abdominal pain, diarrhea, and other symptoms. Guselkumab is already used in adults with certain inflammatory conditions, and this trial is studying how it works in pediatric patients. **You may be eligible if:** - Your child has been diagnosed with Crohn's disease (confirmed by clinical, endoscopic, and tissue examination findings) - Your child has moderately to severely active disease based on a standard scoring tool (PCDAI score of 30 or higher) - Your child has active disease visible on endoscopy (colonoscopy) - Your child has previously tried and failed, lost response to, or could not tolerate standard treatments including steroids, immunosuppressants, or biologic drugs **You may NOT be eligible if:** - Your child has severe complications such as bowel narrowing or short gut syndrome - Your child has an abscess (a pocket of infection) - Your child has had bowel surgery within the past 6 months or any abdominal surgery within the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGuselkumab

Guselkumab will be administered subcutaneously.

DRUGGuselkumab

Guselkumab will be administered intravenously.

Locations(84)

Cedars Sinai Medical Center

Los Angeles, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Emory University

Atlanta, Georgia, United States

Children's Center for Digestive Health Care

Atlanta, Georgia, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Boston Childrens Hospital

Boston, Massachusetts, United States

Goryeb Children's Hospital

Morristown, New Jersey, United States

Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

The Children's Medical Center of Dayton

Dayton, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Cook Childrens Medical Center

Fort Worth, Texas, United States

University of Vermont Medical Center

Colchester, Vermont, United States

Perth Children's Hospital

Nedlands, Australia

Mater Hospital Brisbane

South Brisbane, Australia

The Children's Hospital at Westmead

Westmead, Australia

AKH - Medizinische Universitat Wien

Vienna, Austria

Universitair Ziekenhuis Brussel

Brussels, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, Brazil

Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro

Curitiba, Brazil

Universidade Federal de Goias - Hospital das Clinicas da UFG

Goiânia, Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

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

Vitória, Brazil

INTEGRAL Pesquisa e Ensino

Votuporanga, Brazil

Iwk Health Centre

Halifax, Nova Scotia, Canada

London Health Sciences Centre Victoria Hospital

London, Ontario, Canada

Hospital For Sick Children

Toronto, Ontario, Canada

CHU Amiens-Hopital Nord

Amiens, France

Hôpital Jeanne de FLANDRE, CHRU LILLE

Lille, France

Hôpital Necker - Enfants Malades

Paris, France

Hôpital Robert Debré

Paris, France

Soroka University Medical Center

Beersheba, Israel

Shamir Medical Center Assaf Harofeh

Be’er Ya‘aqov, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

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

Bergamo, Italy

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

Bologna, Italy

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

Florence, Italy

Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi

Milan, Italy

AOU Policlinico Umberto I

Roma, Italy

Hirosaki University Hospital

Hirosaki, Japan

Kagoshima University Hospital

Kagoshima, Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Japan

Kobe University Hospital

Kobe, Japan

Saga University Hospital

Saga, Japan

Miyagi Children's Hospital

Sendai, Japan

National Center for Child Health and Development

Setagaya Ku, Japan

Juntendo University Hospital

Tokyo, Japan

Mie University Hospital

Tsu, Japan

Yamaguchi University Hospital

Ube, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Japan

Yokohama City University Medical Center

Yokohama, Japan

Erasmus Medisch Centrum

Rotterdam, Netherlands

Akershus Universitetssykehus HF

Nordbyhagen, Norway

Oslo University Hospital

Oslo, Norway

Universitetssykehuset Nord-Norge HF

Tromsø, Norway

St. Olavs Hospital

Trondheim, Norway

Korczowski Bartosz Gabinet Lekarski

Rzeszów, Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Instytut Pomnik Centrum Zdrowia

Warsaw, Poland

Hospital de Braga

Braga, Portugal

Centro Hospitalar de Lisboa Norte Hospital Santa Maria

Lisbon, Portugal

Centro Hospitalar de Sao Joao E.P.E.

Porto, Portugal

Inje University Haeundae Paik Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Hosp Reina Sofia

Córdoba, Spain

Corporacio Sanitari Parc Tauli

Sabadell, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Royal Hospital for Sick Children

Glasgow, United Kingdom

Great Ormond Street Hospital

London, United Kingdom

Nowgen Centre, Research and Innovation

Manchester, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom

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NCT05923073

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