Vedolizumab safety check in kids with IBD shows promise

NCT ID NCT03196427

Completed Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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