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New hope for kids with severe gut disease: drug shows promise in remission

NCT ID NCT04779307

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a medicine called vedolizumab in 121 children with moderate to severe ulcerative colitis, a condition causing inflammation and pain in the gut. The goal was to see if the drug could help children achieve remission, meaning their symptoms improve and tests show little to no disease. Participants first received three infusions over six weeks, then those who responded continued with maintenance doses every eight weeks. The study also monitored side effects to ensure safety.

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

121 people

The number who actually took part.

Started

Oct 2021

Finished

Jul 2025

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. Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC). 2. Weighs ≥10 kg at the time of screening and enrollment into the study. 3. Participants with UC diagnosed at least 1 month before screening. Participants with moderately to severely active UC based on 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) at screening endoscopy. 4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], methotrexate \[MTX\]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids. 5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum. 6. Has 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. 7. Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines. Exclusion Criteria: 1. Has 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 or rituximab. 2. Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period. 3. Has 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. 4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 30 days prior to first dose of study drug. 5. Has received any live vaccinations within 30 days prior to first dose of study drug. 6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study. 7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine. 8. Participants with a current diagnosis of indeterminate colitis. 9. Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease. 10. Participant with 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. NOTE: If participants have received Bacillus Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test. 11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie, 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. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV RNA). Note: Subjects 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 participant has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. 13. Has positive stool studies for ova and/or parasites or stool culture at screening visit. 14. Has 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.

ulcerative colitis

As listed by the trial registrant

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

Colitis ulcerative

Contacts and locations

Locations

  • AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2

    Naples, 280138, Italy

  • Advocate Children's Hospital Park Ridge

    Park Ridge, Illinois, 60068, United States

  • Attikon University General Hospital

    Chaïdári, Attica, 124 62, Greece

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza

    Rome, Lazio, 00161, Italy

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

    Florence, Tuscany, 50139, Italy

  • Azienda USL di Bologna

    Bologna, Emilia-Romagna, 40133, Italy

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

    Beijing, Beijing Municipality, 100045, China

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

    Birmingham, West Midlands, B4 6NH, United Kingdom

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

    Miskolc, 3526, Hungary

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4, Canada

  • Carilion Children's Tanglewood Center

    Roanoke, Virginia, 24013-2253, United States

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Children's Hospital "Agia Sofia"

    Athens, Attica, 115 27, Greece

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102, China

  • Childrens Center For Digestive Healthcare

    Atlanta, Georgia, 30318-4833, United States

  • Clinexpert Gyogycentrum

    Budapest, 1033, Hungary

  • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo

    Monza, Monza E Brianza, 20900, Italy

  • Gachon University Gil Medical Center

    Seoul, Incheon Gwang'yeogsi, 3080, South Korea

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

    Katowice, Silesian Voivodeship, 40-752, Poland

  • Goryeb Children's Hospital

    Morristown, New Jersey, 07960-6136, United States

  • Great Ormond Street Hospital

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

  • Hadassah Medical Center - PPDS

    Jerusalem, Jerusalem, 91120, Israel

  • Henan Children's Hospital Zhengzhou Children's Hospital

    Zhengzhou, Henan, 450000, China

  • Instytut 'Pomnik - Centrum Zdrowia Dziecka'

    Warsaw, Masovian Voivodeship, 04-736, Poland

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Ippokratio General Hospital of Thessaloniki

    Thessaloniki, 546 42, Greece

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520, Japan

  • Juntendo University Hospital

    Bunkyo-Ku, Tokyo, 113-8431, Japan

  • Klinika Za Djecje Bolesti Zagreb

    Zagreb, City of Zagreb, 10000, Croatia

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

  • Kurume University Hospital

    Kurume, Hukuoka, 830-0011, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, Daegu Gwang'yeogsi, 41404, South Korea

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • MNGI Digestive Health PA-Plymouth

    Minneapolis, Minnesota, 55413, United States

  • Mayo Clinic - PIN

    Rochester, Minnesota, 55905-0001, United States

  • Monash Health, Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • National Center for Child Health and Development

    Setagaya-ku, Tokyo, 157-8535, Japan

  • Noahs Ark Childrens Hospital for Wales

    Cardiff, CF14 4XW, United Kingdom

  • Phoenix Childrens Hospital -1919 E Thompson Rd

    Phoenix, Arizona, 85016-7710, United States

  • Queensland Childrens Hospital

    South Brisbane, Queensland, 4101, Australia

  • Rady Childrens Hospital San Diego - PIN

    San Diego, California, 92123, United States

  • Rambam Medical Center - PPDS

    Haifa, 31096, Israel

  • Royal Children's Hospital Melbourne - PIN

    Parkville, Victoria, 3052, Australia

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

    Lodz, Łódź Voivodeship, 91-738, Poland

  • Saitama Children's Medical Center

    Saitama, 330-8777, Japan

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Schneider Childrens Medical Center of Israel Petah Tikvah PIN

    Petah Tikva, 49100, Israel

  • Semmelweis Egyetem

    Budapest, 1085, Hungary

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 21565, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 91031, Israel

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Texas Childrens Hospital West Campus

    Houston, Texas, 77030-2358, United States

  • The Children's Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The Royal London Hospital

    London, London, City of, E1 1BB, United Kingdom

  • Twoja Przychodnia SCM

    Szczecin, West Pomeranian Voivodeship, 71-434, Poland

  • UPMC Children's Hospital of Pittsburgh-120 Lytton Ave

    Pittsburgh, Pennsylvania, 15224-1334, United States

  • UZ Antwerpen

    Edegem, Antwerpen, 2650, Belgium

  • Universitair Ziekenhuis Brussel - PIN

    Jette, Brussels Capital, 1090, Belgium

  • Universitaire Ziekenhuizen(UZ)Leuven-Campus Gasthuisberg

    Leuven, Vlaams Brabant, 3000, Belgium

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2S2, Canada

  • Uniwersytecki Szpital Dzieciecy

    Krakow, Lesser Poland Voivodeship, 30-663, Poland

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, Masovian Voivodeship, 00-728, Poland

More trials for these conditions

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