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Kids with IBD get long-term safety check on vedolizumab

NCT ID NCT06405087

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at the long-term safety of a drug called vedolizumab given as a shot under the skin to children and teenagers with ulcerative colitis or Crohn's disease. About 70 participants who did well on the drug in an earlier study will keep getting it, while those who didn't respond well will be watched for up to 2 years. The goal is to track any side effects and see how the drug affects hospital visits and quality of life.

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

Oct 2025

Expected to finish

Aug 2030

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 for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of \>=2 points and \>= 25 percentage (%) from baseline (from VedolizumabSC-3003 \[NCT06100289\]), including a \>=1-point decrease in the Mayo stool frequency subscore and a \>=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (\<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) \<=30 with a reduction in the PCDAI of \>=15 points from baseline (from VedolizumabSC-3003 \[NCT06100289\]). Inclusion Criteria for Observational Cohort 1\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study. Exclusion Criteria for Treatment Cohort 1. Has hypersensitivity or allergies to vedolizumab or any of its excipients. 2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.

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Get notified about this study

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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

    54 sites in 16 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

  • ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN

    NOT_YET_RECRUITING

    Milan, Italy

  • Advocate Children's Hospital Park Ridge

    NOT_YET_RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Atlantic Health - Morristown Medical Center

    NOT_YET_RECRUITING

    Morristown, New Jersey, 07960, United States

  • Azienda Ospedaliera Universitaria Gaetano Martino, Messina

    NOT_YET_RECRUITING

    Messina, 98124, Italy

  • Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu

    NOT_YET_RECRUITING

    Roma, 165, Italy

  • Centre Hospitalier Chretien MontLegia

    NOT_YET_RECRUITING

    Liège, Belgium

  • Centre Hospitalier Universitaire Vaudois

    NOT_YET_RECRUITING

    Lausanne, 1011, Switzerland

  • Centro Hospitalar do Porto - Hospital de Santo Antonio

    NOT_YET_RECRUITING

    Porto, 4099-001, Portugal

  • Changhua Christian Medical Foundation - Changhua Christian Children's Hospital

    NOT_YET_RECRUITING

    Changhua, 500010, Taiwan

  • Children's Hospital of Orange County

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • Childrens Health Ireland at Crumlin - PIN

    NOT_YET_RECRUITING

    Crumlin, Dublin, Ireland

  • Childrens Hospital of Michigan

    NOT_YET_RECRUITING

    Detroit, Michigan, 48201, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cliniques Universitaires Saint-Luc

    NOT_YET_RECRUITING

    Brussels, Brussels Capital, Belgium

  • Grigore Alexandrescu Emergency Clinical Hospital for Children

    RECRUITING

    Bucharest, Romania

  • Hospitais da Universidade de Coimbra

    NOT_YET_RECRUITING

    Coimbra, 3000-602, Portugal

  • Hospital Arquitecto Marcide de Ferrol

    NOT_YET_RECRUITING

    Ferrol, 15405, Spain

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

    NOT_YET_RECRUITING

    Lisbon, 1649-035, Portugal

  • Hospital Universitario 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen Macarena

    NOT_YET_RECRUITING

    Seville, 41009, Spain

  • Hvidovre Hospital

    NOT_YET_RECRUITING

    Hvidovre, Capital Region, 2650, Denmark

  • Institute for Children and Youth Health Care of Vojvodina

    NOT_YET_RECRUITING

    Novi Sad, Serbia

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    RECRUITING

    Warsaw, Poland

  • Juntendo University Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    NOT_YET_RECRUITING

    Kaohsiung City, 807, Taiwan

  • Korczowski Bartosz, Gabinet Lekarski

    RECRUITING

    Rzeszów, 35-302, Poland

  • Kurume University Hospital

    NOT_YET_RECRUITING

    Kurume-shi, Fukuoka, 830-0011, Japan

  • Kyungpook National University Chilgok hospital

    RECRUITING

    Daegu, South Korea

  • Loma Linda University

    NOT_YET_RECRUITING

    Loma Linda, California, 92350, United States

  • Medical University of South Carolina

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

    NOT_YET_RECRUITING

    Belgrade, Serbia

  • Multicare Health System Institute for Research and Innovation

    NOT_YET_RECRUITING

    Tacoma, Washington, 98405, United States

  • National Center for Child Health and Development

    NOT_YET_RECRUITING

    Setagaya-ku, Tokyo, 157-8535, Japan

  • National Taiwan University Hospital

    NOT_YET_RECRUITING

    Zhongzheng, 100, Taiwan

  • New York Presbyterian Hospital

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • Penn State Health Milton South Hershey Medical Center

    NOT_YET_RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Phoenix Childrens Hospital

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85016, United States

  • Pius Brinzeu Emergency Clinical County Hospital

    NOT_YET_RECRUITING

    Timișoara, Timiș County, Romania

  • Radboud Universitair Medisch Centrum

    NOT_YET_RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego

    NOT_YET_RECRUITING

    Zabrze, Poland

  • Samsung Medical Center

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 3080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Stanford Children's Health

    NOT_YET_RECRUITING

    Palo Alto, California, 94304, United States

  • The University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • UMHAT Sv. Georgi, EAD

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Unita Operativa Complessa Di Pediatria Medica

    NOT_YET_RECRUITING

    Pescara, 65125, Italy

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    NOT_YET_RECRUITING

    Valencia, 46026, Spain

  • University Children's Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Children's Clinic

    NOT_YET_RECRUITING

    Belgrade, 11000, Serbia

  • University Children's Hospital Zurich

    NOT_YET_RECRUITING

    Zurich, 8032, Switzerland

  • University Hospital of Bern

    RECRUITING

    Bern, 03010, Switzerland

  • Victor Gomoiu Clinical Hospital for Children

    RECRUITING

    Bucharest, Bucharest, Romania

  • WIP Warsaw IBD Point Profesor Kierkus

    RECRUITING

    Warsaw, 04-501, Poland

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