Ulcerative Colitis study: Vedolizumab IV
Official title A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
ClinicalTrials.gov ID: NCT05442567
What this study is testing
What is Vedolizumab IV?
An investigational intravenous infusion being studied as a potential treatment for ulcerative colitis in children. is designed to block the interaction between integrin α4β7 and mucosal addressin cell adhesion molecule-1, thereby reducing gut inflammation.
Also referred to as ENTYVIO, KYNTELES.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to collect long‑term safety data for vedolizumab in children with UC or CD.
- Who it's for
- Children who have already participated in one of the two earlier studies.
- What's involved
- Participants will continue to receive vedolizumab and attend scheduled safety visits.
- Time commitment
- The study lasts until the end of the extension period, with visits scheduled as in the parent studies.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has...
- A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g...
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of...
You likely can't join if
- The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical...
- The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or...
- The participant has other serious comorbidities that will limit their ability to complete the study.
- The participant is unable to comply with all study assessments.
- The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
- The participant is lactating or pregnant.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Park Ridge, Illinois, United States
- Roanoke, Virginia, United States
- Westmead, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Parkville, Victoria, Australia
- Edegem, Antwerpen, Belgium
- Jette, Brussels Capital, Belgium
- Leuven, Vlaams Brabant, Belgium
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Zagreb, City of Zagreb, Croatia
- Athens, Attica, Greece
- Athens, Greece
- Thessaloniki, Greece
- Miskolc, Borsod-Abauj Zemplen county, Hungary
- Budapest, Hungary
- Jerusalem, Jerusalem, Israel
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Park Ridge, Illinois, United States; Roanoke, Virginia, United States; Westmead, New South Wales, Australia; South Brisbane, Queensland, Australia; Parkville, Victoria, Australia and 33 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.