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Vedolizumab safety check for kids with IBD continues

NCT ID NCT05442567

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is for children with ulcerative colitis or Crohn's disease who already completed a previous vedolizumab trial. It aims to see how safe the drug is over a longer period. About 240 kids will receive vedolizumab infusions or be observed without treatment. Researchers will track side effects and major bowel-related events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vedolizumab (a biologic drug given by IV infusion)
What this could lead to
If successful, this study could confirm that vedolizumab is safe for long-term use in children with inflammatory bowel disease, offering a reliable treatment option.
What could go wrong
This is an extension study focused on safety, not on proving new benefits. It may not show major improvements, and side effects like infections or allergic reactions are possible.

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 240 people

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

Started

May 2023

Expected to finish

Feb 2033

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 years and older

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.

Main Inclusion Criteria: For Treatment Cohort: 1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30. 2. A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception. 3. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose. For Observational Cohort: 1\. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study. Main Exclusion Criteria: For Treatment Cohort only: 1. The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study. 2. The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety. 3. The participant has other serious comorbidities that will limit their ability to complete the study. 4. The participant is unable to comply with all study assessments. 5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients. 6. The participant is lactating or pregnant.

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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

    52 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

  • Advocate Children's Hospital - Park Ridge - PIN

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Azienda Ospedaliera Universitaria Federico II

    RECRUITING

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2

    RECRUITING

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliero Universitaria A Meyer

    TERMINATED

    Florence, Tuscany, 50139, Italy

  • Azienda USL di Bologna

    RECRUITING

    Bologna, Emilia-Romagna, 40133, Italy

  • Barts Health NHS Trust - PPDS

    NOT_YET_RECRUITING

    London, E1 1BB, United Kingdom

  • Beijing Children's Hospital, Capital Medical University - PIN

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100045, China

  • Birmingham Women's and Children's NHS Foundation Trust

    RECRUITING

    Birmingham, Warwickshire, B4 6NH, United Kingdom

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz

    RECRUITING

    Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

  • Boston Children's Hospital - PIN

    WITHDRAWN

    Boston, Massachusetts, 02215, United States

  • British Columbia Children's Hospital - 4480 Oak St

    WITHDRAWN

    Vancouver, British Columbia, V6H 3N1, Canada

  • Carilion Children's Tanglewood Center

    RECRUITING

    Roanoke, Virginia, 24018, United States

  • Carmel Medical Center

    RECRUITING

    Haifa, 34362, Israel

  • Cedars Sinai Medical Center - 127 San Vicente Blvd

    WITHDRAWN

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire Sainte-Justine

    WITHDRAWN

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Hospital Agia Sofia

    RECRUITING

    Athens, GR11527, Greece

  • Children's Hospital Zagreb

    RECRUITING

    Zagreb, City of Zagreb, 10000, Croatia

  • Children's Hospital at Westmead

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Children's Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201102, China

  • Childrens Center For Digestive Healthcare

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30342, United States

  • Clinexpert Obuda Egeszsegcentruma

    TERMINATED

    Budapest, 1033, Hungary

  • Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN

    WITHDRAWN

    New Hyde Park, New York, 11042, United States

  • Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50

    WITHDRAWN

    Gdansk, Pomeranian Voivodeship, 80-803, Poland

  • Fakultni Thomayerova Nemocnice

    WITHDRAWN

    Prague, Praha, Hlavni Mesto, 140 00, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    WITHDRAWN

    Prague, Praha, Hlavni Mesto, 100 34, Czechia

  • Fondazione IRCCS San Gerardo dei Tintori

    TERMINATED

    Monza, Lombardy, 20900, Italy

  • Gachon University Gil Medical Center

    TERMINATED

    Incheon, Incheon Gwang'yeogsi, 21565, South Korea

  • General Hospital of Thessaloniki ''Hippokratio''

    WITHDRAWN

    Thessaloniki, 546 42, Greece

  • General Hospital of Thessaloniki ''Hippokratio''

    RECRUITING

    Thessaloniki, 546 42, Greece

  • Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach

    WITHDRAWN

    Katowice, Silesian Voivodeship, 40-752, Poland

  • Goryeb Children's Hospital

    TERMINATED

    Morristown, New Jersey, 07960, United States

  • Great Ormond Street Hospital

    WITHDRAWN

    London, London, City of, WC1N 3AJ, United Kingdom

  • Hadassah Medical Center- Ein Kerem - PPDS

    RECRUITING

    Jerusalem, 91120, Israel

  • Hasbro Children's Hospital - PIN

    WITHDRAWN

    Providence, Rhode Island, 02903, United States

  • Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus

    RECRUITING

    Zhengzhou, Henan, 450018, China

  • Hospital Infantil Universitario Nino Jesus - PIN

    WITHDRAWN

    Madrid, 28009, Spain

  • Hospital Regional Universitario de Malaga Hospital Materno-Infantil

    WITHDRAWN

    Málaga, 29011, Spain

  • Hospital Sant Joan de Deu - PIN

    WITHDRAWN

    Barcelona, 8950, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    WITHDRAWN

    Seville, 41013, Spain

  • Hospital de Sagunto

    WITHDRAWN

    Sagunto, Valencia, 46520, Spain

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    WITHDRAWN

    Kaunas, Kaunas County, LT-50161, Lithuania

  • Hunan Children's Hospital

    RECRUITING

    Changsha, Hunan, 410007, China

  • I.H.S Health LLC-Kissimmee-445 W Oak St

    WITHDRAWN

    Kissimmee, Florida, 34741, United States

  • Instytut Centrum Zdrowia Matki Polki

    RECRUITING

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Instytut Pomnik Centrum Zdrowia Dziecka

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-736, Poland

  • Japanese Red Cross Kumamoto Hospital

    RECRUITING

    Kumamoto, Kumamoto, 861-8520, Japan

  • Johns Hopkins University

    WITHDRAWN

    Baltimore, Maryland, 21287, United States

  • Juntendo University Hospital

    RECRUITING

    Bunkyo-Ku, Tokyo, 113-8431, Japan

  • King's College Hospital

    WITHDRAWN

    London, Surrey, SE5 9RS, United Kingdom

  • Korczowski Bartosz, Gabinet Lekarski

    RECRUITING

    Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

  • Kurume University Hospital

    RECRUITING

    Kurume-Shi, Hukuoka, 830-0011, Japan

  • Kyungpook National University Chilgok hospital

    RECRUITING

    Daegu, Daegu Gwang'yeogsi, 41404, South Korea

  • London Health Sciences Centre -800 Commissioners Rd E

    TERMINATED

    London, Ontario, N6A 5W9, Canada

  • MNGI Digestive Health PA-Plymouth

    TERMINATED

    Minneapolis, Minnesota, 55413, United States

  • Mayo Clinic - PIN

    TERMINATED

    Rochester, Minnesota, 55905, United States

  • Monash Health, Monash Medical Centre

    NOT_YET_RECRUITING

    Clayton, Victoria, 3168, Australia

  • Narodny ustav detskych chorob

    WITHDRAWN

    Bratislava, 833 40, Slovakia

  • National Center for Child Health and Development

    RECRUITING

    Setagaya-Ku, Tokyo, 157-8535, Japan

  • Noahs Ark Childrens Hospital for Wales - PIN

    WITHDRAWN

    Cardiff, South Glamorgan, CF14 4XW, United Kingdom

  • Phoenix Childrens Hospital - Thomas Rd - PIN

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Queensland Childrens Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Rady Children's Hospital - San Diego - PIN

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Rambam Health Care Campus PPDS

    RECRUITING

    Haifa, 31096, Israel

  • Riley Hospital For Children - PIN

    WITHDRAWN

    Indianapolis, Indiana, 46202, United States

  • Royal Children's Hospital Melbourne - PIN

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Royal Manchester Children's Hospital - PPDS - PIN

    WITHDRAWN

    Manchester, M27 4HA, United Kingdom

  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251

    RECRUITING

    Lodz, 91-738, Poland

  • Saitama Children's Medical Center-1397-1 yamane

    RECRUITING

    Hidaka, Saitama, 330-8777, Japan

  • Samsung Medical Center

    RECRUITING

    Seoul, 6351, South Korea

  • Sapienza University of Rome

    RECRUITING

    Rome, Lazio, 185, Italy

  • Schneider Childrens Medical Center of Israel Petah Tikvah PIN

    TERMINATED

    Petah Tikva, 49100, Israel

  • Semmelweis Egyetem, Pulmonologiai Klinika

    RECRUITING

    Budapest, 1083, Hungary

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, Jerusalem, 91031, Israel

  • Soroka University Medical Centre

    WITHDRAWN

    Beersheba, 84101, Israel

  • Stony Brook University Medical Center

    WITHDRAWN

    Stony Brook, New York, 11794, United States

  • Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai Klinika

    WITHDRAWN

    Szeged, Csongrád megye, 6720, Hungary

  • Tel Aviv Sourasky Medical Center Ichilov - PPDS

    RECRUITING

    Jerusalem, Jerusalem, 90000, Israel

  • Texas Children's Hospital - Baylor - PIN

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Twoja Przychodnia SCM - Slowackiego

    RECRUITING

    Szczecin, West Pomeranian Voivodeship, 71-434, Poland

  • UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15201, United States

  • UZ Antwerpen - PIN

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • UZ Brussel - PIN

    RECRUITING

    Jette, Brussels Capital, 1090, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, Vlaams Brabant, 3000, Belgium

  • Universita degli Studi di Padova

    WITHDRAWN

    Padova, Veneto, 35122, Italy

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

    RECRUITING

    Athens, Attica, 12462, Greece

  • University Hospital Center Zagreb

    WITHDRAWN

    Zagreb, City of Zagreb, 10000, Croatia

  • University Hospital of Split-Spinciceva 1

    WITHDRAWN

    Split, 21000, Croatia

  • University Hospitals Cleveland Medical Center - 11100 Euclid Ave

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alberta Hospital

    WITHDRAWN

    Edmonton, Alberta, T6G 2B7, Canada

  • University of California San Francisco

    WITHDRAWN

    San Francisco, California, 94158, United States

  • University of Rochester Medical Center - PPDS

    WITHDRAWN

    Rochester, New York, 14642, United States

  • University of South Alabama (USA) Physicians Group

    NOT_YET_RECRUITING

    Mobile, Alabama, 36604, United States

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-663, Poland

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Pasteura 4

    WITHDRAWN

    Wroclaw, Lower Silesian Voivodeship, 50-369, Poland

  • Vilnius University Hospital Santaros Klinikos

    WITHDRAWN

    Vilnius, Vilnius County, 8406, Lithuania

  • WIP Warsaw IBD Point Profesor Kierkus

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-501, Poland

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