MedTrace Logo

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

NCT06100289 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-15

No results posted yet for this study

Summary

The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).

The participants will be treated with vedolizumab for up to 34 weeks.

During the study, participants will visit their study clinic several times.

Conditions

Interventions

DRUG

Vedolizumab IV

Vedolizumab IV injection.

DRUG

Vedolizumab SC

Vedolizumab SC injection.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2027-11-15
Completion
2027-11-15
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Denmark
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Serbia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100289 on ClinicalTrials.gov