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A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

NCT04779320

This study is recruiting at 8 US sites in 7 states, according to its ClinicalTrials.gov record last updated .

Summary

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Crohn's Disease (CD)

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
2 to 17 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Takeda
Last updated on ClinicalTrials.gov
May 5, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Georgia · 1

  • Childrens Center For Digestive Healthcare · Atlanta, GA

Illinois · 1

  • Advocate Children's Hospital Park Ridge · Park Ridge, IL

Minnesota · 1

  • MNGI Digestive Health, PA · Minneapolis, MN

New Jersey · 1

  • Goryeb Children's Hospital · Morristown, NJ

New York · 2

  • The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS · New Hyde Park, NY
  • Stony Brook University Medical Center · Stony Brook, NY

Texas · 1

  • Texas Children's Hospital · Houston, TX

Virginia · 1

  • Carilion Children's Tanglewood Center · Roanoke, VA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.