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New hope for kids with Crohn's: drug trial targets gut healing

NCT ID NCT05923073

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests a drug called guselkumab in 120 children with moderate to severe Crohn's disease. The goal is to see if it can reduce symptoms and heal the gut lining over 52 weeks. Participants must have active Crohn's confirmed by endoscopy. This is a phase 3 trial, meaning it's in the final testing stage before possible approval.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    84 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O. Santi Antonio e Biagio e Cesare Arrigo

    RECRUITING

    Alessandria, 15121, Italy

  • AKH - Medizinische Universitat Wien

    RECRUITING

    Vienna, 1090, Austria

  • AOU Policlinico Umberto I

    RECRUITING

    Roma, 161, Italy

  • Akershus Universitetssykehus HF

    RECRUITING

    Nordbyhagen, 1474, Norway

  • Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro

    RECRUITING

    Curitiba, 80250-060, Brazil

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    RECRUITING

    Florence, 50139, Italy

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

    RECRUITING

    Milan, 20154, Italy

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

    RECRUITING

    Bergamo, 24127, Italy

  • Boston Childrens Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHU Amiens-Hopital Nord

    RECRUITING

    Amiens, 80054, France

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centro Hospitalar de Lisboa Norte Hospital Santa Maria

    RECRUITING

    Lisbon, 1649-035, Portugal

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

    RECRUITING

    Porto, 4200-319, Portugal

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

    RECRUITING

    Vitória, 29040-091, Brazil

  • Children's Center for Digestive Health Care

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cliniques Universitaires Saint Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Cook Childrens Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Corporacio Sanitari Parc Tauli

    RECRUITING

    Sabadell, 8208, Spain

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Erasmus Medisch Centrum

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Goryeb Children's Hospital

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Great Ormond Street Hospital

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9124001, Israel

  • Hirosaki University Hospital

    RECRUITING

    Hirosaki, 036-8563, Japan

  • Hosp Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • Hosp. Univ. I Politecni La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital De Clinicas De Porto Alegre

    RECRUITING

    Porto Alegre, 90035-007, Brazil

  • Hospital For Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Hospital de Braga

    RECRUITING

    Braga, 4710-243, Portugal

  • Hôpital Jeanne de FLANDRE, CHRU LILLE

    RECRUITING

    Lille, 59037, France

  • Hôpital Necker - Enfants Malades

    RECRUITING

    Paris, 75015, France

  • Hôpital Robert Debré

    RECRUITING

    Paris, 75019, France

  • INTEGRAL Pesquisa e Ensino

    RECRUITING

    Votuporanga, 100000, Brazil

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Inje University Haeundae Paik Hospital

    RECRUITING

    Busan, 48108, South Korea

  • Instytut Pomnik Centrum Zdrowia

    RECRUITING

    Warsaw, 04 730, Poland

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    RECRUITING

    Porto Alegre, 90035-074, Brazil

  • Iwk Health Centre

    RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

  • John Radcliffe Hospital

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Juntendo University Hospital

    RECRUITING

    Tokyo, 113-8431, Japan

  • Kagoshima University Hospital

    RECRUITING

    Kagoshima, 890-8544, Japan

  • Kaplan Medical Center

    RECRUITING

    Rehovot, 761001, Israel

  • Kobe University Hospital

    RECRUITING

    Kobe, 650 0017, Japan

  • Korczowski Bartosz Gabinet Lekarski

    RECRUITING

    Rzeszów, 35-302, Poland

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, 41404, South Korea

  • London Health Sciences Centre Victoria Hospital

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Mater Hospital Brisbane

    RECRUITING

    South Brisbane, 4101, Australia

  • Mie University Hospital

    RECRUITING

    Tsu, 514 8507, Japan

  • Miyagi Childrens Hospital

    RECRUITING

    Sendai, 989-3126, Japan

  • National Center for Child Health and Development

    RECRUITING

    Setagaya Ku, 157 8535, Japan

  • Nowgen Centre, Research and Innovation

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Oslo University Hospital

    RECRUITING

    Oslo, 424, Norway

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

    RECRUITING

    Bologna, 40124, Italy

  • Perth Children's Hospital

    RECRUITING

    Nedlands, 6009, Australia

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202-5225, United States

  • Royal Hospital for Sick Children

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Royal Manchester Children's Hospital

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Saga University Hospital

    RECRUITING

    Saga, 849-8501, Japan

  • Saiseikai Yokohamashi Tobu Hospital

    RECRUITING

    Yokohama, 230-8765, Japan

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Schneider Children's Medical Center

    RECRUITING

    Petah Tikva, 4920235, Israel

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 120-752, South Korea

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • Shamir Medical Center Assaf Harofeh

    RECRUITING

    Be’er Ya‘aqov, 70300, Israel

  • Sheffield Children's Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

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

    RECRUITING

    Campinas, 13060-904, Brazil

  • Soroka University Medical Center

    RECRUITING

    Beersheba, 84101, Israel

  • St. Olavs Hospital

    RECRUITING

    Trondheim, 7030, Norway

  • The Children's Hospital at Westmead

    RECRUITING

    Westmead, 2145, Australia

  • The Children's Medical Center of Dayton

    COMPLETED

    Dayton, Ohio, 45404, United States

  • Tsujinaka Hospital Kashiwanoha

    RECRUITING

    Kashiwa-shi, 277-0871, Japan

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    RECRUITING

    Goiânia, 74605-020, Brazil

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Universitetssykehuset Nord-Norge HF

    RECRUITING

    Tromsø, 9038, Norway

  • University of Vermont Medical Center

    RECRUITING

    Colchester, Vermont, 05446, United States

  • WIP Warsaw IBD Point Profesor Kierkus

    RECRUITING

    Warsaw, 04 501, Poland

  • Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center

    RECRUITING

    New York, New York, 10021-5663, United States

  • Yamaguchi University Hospital

    RECRUITING

    Ube, 755-8505, Japan

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, 232-0024, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.