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Vedolizumab safety check in kids with IBD shows promise

NCT ID NCT03196427

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of vedolizumab, a biologic drug given by IV, in 59 children with ulcerative colitis or Crohn's disease. Participants had already completed a previous study and continued treatment to monitor for side effects. The goal was to see if the drug is safe for ongoing use in young patients.

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 could confirm that vedolizumab is safe for long-term use in children with inflammatory bowel disease, offering a treatment option to control symptoms.
What could go wrong
This is a small, phase 2 extension study focused on safety, not effectiveness. It may not show clear benefits, and side effects are possible. Results may not apply to all children.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

59 people

The number who actually took part.

Started

Jul 2018

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. Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003. (Note: A participant remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.) 2. Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of \>=2 points and \>=25% from Baseline, or a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of \>=20 points from baseline for participants with UC; or a reduction of the CDAI as defined by a \>=70-point decrease from Baseline or a decrease of Pediatric Crohn's Disease Activity Index (PCDAI) of \>=15 points for participants with CD. 3. May be receiving a therapeutic dose of the following drugs: * Oral 5-aminosalicylic acid (5-ASA) compounds. * Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to \[\<=\] 50 milligram per day \[mg/day\]) provided the participant was receiving this medication during prior participation in MLN0002-2003. * Topical (rectal) treatment with 5-ASA or corticosteroids. * Probiotics (example, Saccharomyces boulardii). * Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea. * Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole). * Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003. 4. The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003. Exclusion Criteria: 1. Is female and is lactating or pregnant. 2. Has hypersensitivity or allergies to vedolizumab or any of its excipients. 3. Has withdrawn from Study MLN0002-2003. 4. 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. 5. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug. 6. 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. 7. Has other serious comorbidities that will limit his or her ability to complete the 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

Contacts and locations

Locations

  • BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

    Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

  • Barts and The London NHS Trust

    London, England, E1 1BB, United Kingdom

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic

    Lodz, Łódź Voivodeship, 91-738, Poland

  • Children's Center for Digestive Healthcare

    Atlanta, Georgia, 30342, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Columbia University Medical Center

    New York, New York, 10031, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106-3322, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

    Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

  • Hopital Necker-Enfants Malades

    Paris, Île-de-France Region, 75015, France

  • Kharkiv Regional Clinical Children's Hospital

    Kharkiv, 61093, Ukraine

  • Nemours Childrens Specialty Care - Jacksonville

    Jacksonville, Florida, 32207, United States

  • Schneider Children's Medical Center of Israel

    Petach Tiqwa, 4920235, Israel

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrád megye, 6720, Hungary

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

    Ramat Gan, Tel Aviv, 52621, Israel

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, Lesser Poland Voivodeship, 30-663, Poland

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