Vedolizumab safety check for kids with IBD continues

NCT ID NCT05442567

Recruiting now Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

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.

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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

Contacts and locations

Show contact details

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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