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New shot for kids with Crohn's or colitis shows promise in phase 3 trial

NCT ID NCT06100289

Disease control Sponsor: Takeda 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 2 times

Summary

This study looks at how children and teenagers with moderate to severe ulcerative colitis or Crohn's disease process a drug called vedolizumab when given as a shot under the skin. About 70 participants who already responded to vedolizumab given through a vein will receive the shot for up to 34 weeks. The goal is to check the drug levels in the blood, safety, and whether the body makes antibodies against it.

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 70 people

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

Started

Jan 2025

Expected to finish

May 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: 1. The participant weighs ≥10 kg at the time of screening and enrollment into the study. 2. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as: * Participants with UC: a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2). (The results of screening endoscopy should be applied.) * Participants with CD: a pediatric Crohn's disease activity index (PCDAI) \>30 and a simple endoscopic score for Crohn's disease (SES-CD) \>6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy. 3. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (for example, azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], methotrexate \[MTX\]), and/or tumor necrosis factor (TNF)-α antagonist therapy (for example, infliximab, adalimumab). 4. Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum. 5. Participants with extensive colitis or pancolitis of \>8 years' duration or left-sided colitis of \>12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening. 6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines. Exclusion Criteria: 1. Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab. 2. Participants who have had prior exposure to vedolizumab. 3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients. 4. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders. 5. The participant has received any live vaccinations within 30 days before first dose of study drug. 6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study. 7. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \>3 small intestine resections. 8. Participants with a current diagnosis of indeterminate colitis. 9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD). 10. Participants with active or latent tuberculosis (TB). 11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (that is, HBsAg negative and hepatitis B surface antibody \[anti-HBs\]-positive) may, however, be included. 12. The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation). 13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit. 14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

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

Crohn's disease Ulcerative colitis

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    29 sites in 13 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • "Emergency County Clinical Hospital ""Pius Brinzeu"""

    ACTIVE_NOT_RECRUITING

    Timișoara, Timiș County, 300226, Romania

  • Advocate Children's Hospital

    ACTIVE_NOT_RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Atlantic Health System

    ACTIVE_NOT_RECRUITING

    Morristown, New Jersey, 07960, United States

  • Azienda Ospedaliera Universitaria Gaetano Martino Messina

    RECRUITING

    Messina, 98124, Italy

  • Centre Hospitalier Chretien MontLegia

    RECRUITING

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio

    ACTIVE_NOT_RECRUITING

    Porto, 4050-165, Portugal

  • Changhua Christian Hospital

    ACTIVE_NOT_RECRUITING

    Changhua, 500010, Taiwan

  • Children's Hospital Of Orange County

    RECRUITING

    Orange, California, 92868, United States

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Childrens Health Ireland

    ACTIVE_NOT_RECRUITING

    Dublin, D12 N512, Ireland

  • Cleveland Clinic Foundation

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Complejo Hospitalario Universitario de Ferrol

    ACTIVE_NOT_RECRUITING

    Ferrol, 15405, Spain

  • Dr Victor Gomoiu Clinical Children Hospital

    RECRUITING

    Bucharest, 022102, Romania

  • Hospital Pediatrico - Unidade Local de Saude de Coimbra

    ACTIVE_NOT_RECRUITING

    Coimbra, 3000-602, Portugal

  • Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Hospital U. Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario 12 de Octubre

    ACTIVE_NOT_RECRUITING

    Madrid, 28041, Spain

  • Hospital Univesritario y Politecnico La Fe. Av Fernando abril Martorell106. Valencia 46026. Spain

    ACTIVE_NOT_RECRUITING

    Valencia, 46026, Spain

  • Hvidovre University Hospital

    ACTIVE_NOT_RECRUITING

    Hvidovre, Capital Region, 2650, Denmark

  • IRCCS Ospedale Pediatrico Bambino Gesu

    ACTIVE_NOT_RECRUITING

    Rome, 00165, Italy

  • Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus

    RECRUITING

    Bern, 3010, Switzerland

  • Institute for Childand YouthHealth Care of Vojvodina

    ACTIVE_NOT_RECRUITING

    Novi Sad, 21000, Serbia

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    RECRUITING

    Warsaw, Masovian Voivodeship, 04730, Poland

  • Juntendo University Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Korczowski Bartosz, Gabinet Lekarski

    RECRUITING

    Rzeszów, 35302, Poland

  • Kurume University Hospital

    ACTIVE_NOT_RECRUITING

    Kurume, Fukuoka, 830-0011, Japan

  • Kyungpook National University Chilgok Hospital (KNUCH)

    RECRUITING

    Daegu, 41404, South Korea

  • Loma Linda University School of Medicine

    ACTIVE_NOT_RECRUITING

    Loma Linda, California, 92354, United States

  • Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus

    RECRUITING

    Warsaw, 04-501, Poland

  • Medical University of South Carolina

    NOT_YET_RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Mother and child helath care Institute of Serbia dr Vukan Cupic

    ACTIVE_NOT_RECRUITING

    Belgrade, 11070, Serbia

  • MultiCare Institute for Research & Innovation

    NOT_YET_RECRUITING

    Tacoma, Washington, 98405, United States

  • National Center for Child Health and Development (NCCHD)

    ACTIVE_NOT_RECRUITING

    Setagaya-Ku, Tokyo, 157-8535, Japan

  • National Taiwan University Children's Hospital

    RECRUITING

    Taipei, Zhongzheng Dist, 100, Taiwan

  • New York Presbyterian Hospital, Weill Cornell Medical College

    ACTIVE_NOT_RECRUITING

    New York, New York, 10065, United States

  • Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine

    ACTIVE_NOT_RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Phoenix Children's Hospital

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85016, United States

  • Radboud University Medical Center

    ACTIVE_NOT_RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach

    ACTIVE_NOT_RECRUITING

    Zabrze, 41-800, Poland

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,

    RECRUITING

    Bucharest, 11743, Romania

  • Stanford Children's Health

    ACTIVE_NOT_RECRUITING

    Palo Alto, California, 94304, United States

  • The University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Unita Operativa Complessa Di Pediatria Medica

    ACTIVE_NOT_RECRUITING

    Pescara, 65125, Italy

  • Universitats-Kinderspital

    RECRUITING

    Zurich, 8008, Switzerland

  • University Children's Hospital

    RECRUITING

    Belgrade, 11000, Serbia

  • University Hospital "Saint George"

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • University Hospitals Cleveland Medical Center

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44106, United States

  • V. Buzzi Hospital

    RECRUITING

    Milan, 20154, Italy

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