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

In plain English

What this trial is testing

This study is testing Vedolizumab SC (a drug) and No Intervention as a possible treatment. Condition(s) listed: Ulcerative Colitis and Crohn's Disease.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 2 to 17
• Any sex

Some of the main requirements, copied from the record:

• 1\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the…

There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 70 participants are expected to take part.
• The study has 3 groups.
• Start date: 2025-10-27.
• Main results expected around 2030-08-12 (estimate from the record).
• 47 study sites listed (12 marked recruiting) in Belgium, Bulgaria, Ireland, Italy and Japan and 9 more countries.

Groups in this study

• Treatment Cohort: Vedolizumab 108 mg PFS+AI (listed as: experimental group)
• Treatment Cohort: Vedolizumab 108 mg PFS+NSD (listed as: experimental group)
• Observational Cohort: Early Terminated Participants From Parent Study

Main thing being measured

• Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138))
• Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs) (First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138))
• Observational Cohort: Number of Participants With Prespecified Safety Events (Up to Week 86)

In the researchers’ words

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…

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.