RecruitingPhase 3NCT06405087

A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease


Sponsor

Takeda

Enrollment

70 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up study for children and teenagers who completed a previous clinical trial of vedolizumab — a biologic medication — for Crohn's disease or ulcerative colitis. It monitors how patients do over time and whether long-term treatment continues to be safe and effective. **You may be eligible if...** - You are a child or teenager who completed Week 34 of the previous vedolizumab study (NCT06100289) and responded well (your disease improved and you were off steroids for at least 4 weeks), OR - You received at least one dose in the previous study and either exited early or completed it but did not qualify for the main treatment group **You may NOT be eligible if...** - You are allergic to vedolizumab or any of its ingredients (for the treatment group) - You currently need or are expected to need major bowel surgery (like bowel resection) for your Crohn's disease or colitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVedolizumab SC

Vedolizumab subcutaneous injection.

OTHERNo Intervention

As this is an observational cohort, no intervention will be administered.


Locations(1)

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

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NCT06405087


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