New hope for kids with Crohn's: drug aims to keep disease in check

NCT ID NCT04779320

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a medicine called vedolizumab in children and teens with moderate to severe Crohn's disease. The goal is to see if the drug can reduce inflammation and keep symptoms under control over the long term. Participants first receive three infusions over six weeks, then those who improve continue with either a high or low dose every eight weeks. The study focuses on remission, meaning no symptoms and a clean scope inside the gut.

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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

Feb 2022

Expected to finish

Sep 2027

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.

Main Inclusion Criteria: 1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC). 2. The participants weigh ≥10 kg at the time of screening and enrollment into the study. 3. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) \>30 and an 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. 4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate \[MTX\]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition. 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. Main Exclusion Criteria: 1. Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period. 2. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease. 3. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 30 days prior to first dose of study drug. 4. The participants has received any live vaccinations within 30 days prior to first dose. 5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study. 6. 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. 7. Participants with a current diagnosis of indeterminate colitis. 8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease. 9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as: * Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR * A TB skin test reaction ≥5 mm. 10. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., hepatitis B surface antigen \[HBsAg\]-negative and hepatitis B antibody-positive) may, however, be included. Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory. 11. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV RNA). Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCV RNA at least 12 weeks before baseline\]). 12. The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation). 13. The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. 14. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit. 15. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit. Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohn's disease (CD)

How to take part

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

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

80 sites in 15 countries. The list below names each one and where it is.
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 ↗
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

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
NOT_YET_RECRUITING

Naples, Campania, 80131, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo
NOT_YET_RECRUITING

Monza, Lombardy, 20900, Italy
Advocate Children's Hospital Park Ridge
RECRUITING

Park Ridge, Illinois, 60068, United States
Attikon University General Hospital
RECRUITING

Athens, Attica, 124 62, Greece
Azienda Ospedaliera Universitaria Federico II
NOT_YET_RECRUITING

Naples, Campania, 80131, Italy
Azienda USL di Bologna
NOT_YET_RECRUITING

Bologna, Emilia-Romagna, 40133, Italy
Barts Health NHS Trust
NOT_YET_RECRUITING

London, E1 1BB, United Kingdom
Beijing Children Hospital,Capital Medical University
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100045, China
Birmingham Children's Hospital NHS Foundation Trust
NOT_YET_RECRUITING

Birmingham, West Midlands, B4 6NH, United Kingdom
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
RECRUITING

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary
Boston Children's Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02115, United States
British Columbia Children's Hospital
NOT_YET_RECRUITING

Vancouver, British Columbia, V6H3V4, Canada
Carilion Children's Tanglewood Center
RECRUITING

Roanoke, Virginia, 24018, United States
Carmel Medical Center
NOT_YET_RECRUITING

Haifa, 34362, Israel
Cedars Sinai Medical Center
WITHDRAWN

Los Angeles, California, 90048, United States
Centre Hospitalier Universitaire Sainte-Justine
NOT_YET_RECRUITING

Montreal, Quebec, Canada
Children's Hospital "Agia Sofia"
RECRUITING

Athens, Greece
Children's Hospital at Westmead
NOT_YET_RECRUITING

Westmead, New South Wales, 2145, Australia
Children's Hospital of Fudan University
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 201102, China
Children's Hospital of Pittsburgh
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15201, United States
Childrens Center For Digestive Healthcare
RECRUITING

Atlanta, Georgia, 30342, United States
Copernicus Podmiot Leczniczy Sp. z o.o.
NOT_YET_RECRUITING

Gdansk, Pomeranian Voivodeship, 80-803, Poland
Detska fakultna nemocnica s poliklinikou Banska Bystrica
TERMINATED

Banská Bystrica, 974 09, Slovakia
Fakultni Thomayerova Nemocnice
NOT_YET_RECRUITING

Prague, Praha, Hlavni Mesto, 140 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
NOT_YET_RECRUITING

Prague, Praha, Hlavni Mesto, 100 34, Czechia
Fakultni nemocnice Ostrava
NOT_YET_RECRUITING

Ostrava, Czechia
Gachon University Gil Medical Center
RECRUITING

Incheon, Incheon Gwang'yeogsi, 21565, South Korea
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
NOT_YET_RECRUITING

Katowice, Silesian Voivodeship, 40-752, Poland
Goryeb Children's Hospital
RECRUITING

Morristown, New Jersey, 07960, United States
Great Ormond Street Hospital (GOSH)
NOT_YET_RECRUITING

London, London, City of, WC1N 3AJ, United Kingdom
Hadassah Medical Center - PPDS
NOT_YET_RECRUITING

Jerusalem, 91120, Israel
Hasbro Children's Hospital
WITHDRAWN

Providence, Rhode Island, 02903, United States
Henan Children's Hospital(Zhengzhou Children's Hospital)
NOT_YET_RECRUITING

Zhengzhou, Henan, 450000, 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

Esplugues de Llobregat, 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
I.H.S Health LLC
WITHDRAWN

Kissimmee, Florida, 34741, United States
Instytut Centrum Zdrowia Matki Polki
NOT_YET_RECRUITING

Lodz, Łódź Voivodeship, 93-338, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
RECRUITING

Warsaw, Masovian Voivodeship, 04-736, Poland
Ippokratio General Hospital of Thessaloniki
NOT_YET_RECRUITING

Thessaloniki, 564 29, Greece
Ippokratio General Hospital of Thessaloniki
RECRUITING

Thessaloniki, 564 29, Greece
Japanese Red Cross Kumamoto Hospital
RECRUITING

Kumamoto, Kumamoto, 861-8520, Japan
Johns Hopkins University
NOT_YET_RECRUITING

Baltimore, Maryland, 21287, United States
Juntendo University Hospital
RECRUITING

Bunkyo-Ku, Tokyo, 113-8431, Japan
Kings College Hospital
NOT_YET_RECRUITING

London, London, City of, SE5 9RS, United Kingdom
Klinika Za Djecje Bolesti Zagreb
RECRUITING

Zagreb, City of Zagreb, 10000, Croatia
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
NOT_YET_RECRUITING

London, Ontario, N6A 4G5, Canada
MNGI Digestive Health, PA
RECRUITING

Minneapolis, Minnesota, 55413, United States
Mayo Clinic - PIN
NOT_YET_RECRUITING

Rochester, Minnesota, 55905, United States
Monash Health, Monash Medical Centre
NOT_YET_RECRUITING

Clayton, Victoria, 3168, Australia
Narodny ustav detskych chorob
TERMINATED

Bratislava, 833 40, Slovakia
National Center for Child Health and Development
RECRUITING

Setagaya-Ku, Tokyo, 157-8535, Japan
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
NOT_YET_RECRUITING

Cardiff, South Glamorgan, CF14 4XW, United Kingdom
Phoenix Childrens Hospital
NOT_YET_RECRUITING

Phoenix, Arizona, 85016, United States
Queensland Childrens Hospital
RECRUITING

South Brisbane, Queensland, 4101, Australia
Rady Childrens Hospital San Diego - PIN
NOT_YET_RECRUITING

San Diego, California, 92123, United States
Rambam Medical Center - PPDS
NOT_YET_RECRUITING

Haifa, 31096, Israel
Riley Hospital For Children
WITHDRAWN

Indianapolis, Indiana, 46202, United States
Royal Children's Hospital Melbourne - PIN
NOT_YET_RECRUITING

Parkville, Victoria, 3052, Australia
Royal Manchester Children's Hospital - PPDS
NOT_YET_RECRUITING

Manchester, M27 4HA, United Kingdom
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
NOT_YET_RECRUITING

Lodz, 91-738, Poland
SUNY Upstate Medical Center
WITHDRAWN

Syracuse, New York, 13202, United States
Samsung Medical Center - PPDS
RECRUITING

Seoul, 6351, South Korea
Sapienza University of Rome
RECRUITING

Rome, Lazio, 161, Italy
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
NOT_YET_RECRUITING

Petah Tikva, Central District, 49202, Israel
Semmelweis Egyetem
NOT_YET_RECRUITING

Budapest, 1083, Hungary
Seoul National University Hospital
RECRUITING

Seongnam, Seoul, South Korea
Shaare Zedek Medical Center
NOT_YET_RECRUITING

Jerusalem, 91031, Israel
Soroka University Medical Centre
NOT_YET_RECRUITING

Beersheba, 84101, Israel
Stony Brook University Medical Center
RECRUITING

Stony Brook, New York, 11794, United States
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
RECRUITING

Szeged, Csongrád megye, 6720, Hungary
Tel Aviv Sourasky Medical Center PPDS
NOT_YET_RECRUITING

Jerusalem, Jerusalem, 90000, Israel
Texas Children's Hospital
RECRUITING

Houston, Texas, 77030, United States
The Children's Hospital Zhejiang UniversitySchool of Medicine
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310003, China
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
RECRUITING

New Hyde Park, New York, 11042, United States
Twoja Przychodnia SCM
RECRUITING

Szczecin, West Pomeranian Voivodeship, 71-434, Poland
UZ Antwerpen
NOT_YET_RECRUITING

Edegem, Antwerpen, 2650, Belgium
UZ Leuven
NOT_YET_RECRUITING

Leuven, Vlaams Brabant, 3000, Belgium
Universita degli Studi di Padova
NOT_YET_RECRUITING

Padova, Veneto, 35122, Italy
Universitair Ziekenhuis Brussel - PIN
NOT_YET_RECRUITING

Jette, Brussels Capital, 1090, Belgium
University Hospital Center Zagreb
RECRUITING

Zagreb, City of Zagreb, 10000, Croatia
University Hospital Centre Split
RECRUITING

Split, 21000, Croatia
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING

Cleveland, Ohio, 44106, United States
University of Alberta Hospital
NOT_YET_RECRUITING

Edmonton, Alberta, AB T6G 2B7, Canada
University of California San Francisco
WITHDRAWN

San Francisco, California, 94143, United States
University of Rochester Medical Center PPDS
WITHDRAWN

Rochester, New York, 14642, United States
Uniwersytecki Szpital Dzieciecy
NOT_YET_RECRUITING

Krakow, Lesser Poland Voivodeship, 30-663, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
NOT_YET_RECRUITING

Wroclaw, Lower Silesian Voivodeship, 50-369, Poland
Vilnius University Hospital Santaros Klinikos
WITHDRAWN

Vilnius, Vilnius County, 8406, Lithuania
WIP Warsaw IBD Point Profesor Kierkus
NOT_YET_RECRUITING

Warsaw, Masovian Voivodeship, 00-728, Poland

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