RecruitingPHASE3INTERVENTIONAL

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

This study is checking the long-term safety of a medication called vedolizumab in children and young people who have a type of inflammatory bowel disease, either Crohn's disease or ulcerative colitis. It's a follow-on study for young people who have already taken part in one of two specific earlier studies of vedolizumab. The main goal is to understand if vedolizumab is safe for ongoing use over a longer period in this age group. Patients in the study will continue to receive vedolizumab treatment. Other patients who took part in a previous vedolizumab study but aren't continuing treatment might be asked to join an 'observational' group to be monitored.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Takeda

Enrolment target

240

Start

16 May 2023

Estimated completion

07 Feb 2033

Ulcerative Colitis Crohn's Disease

What is this study about?

This study is looking at a medicine called vedolizumab for children and young people who have two types of gut conditions: ulcerative colitis (UC) or Crohn's disease (CD). These conditions are sometimes called Inflammatory Bowel Disease (IBD). This particular study is an extension, which means it's a follow-up for young people who have already been part of two earlier studies testing vedolizumab. The main reason for this new study is to see how safe vedolizumab is when taken over a longer period.

Researchers want to understand if the medicine has any long-term side effects or if its safety changes with continued use. All the young people taking part in this study will either continue to receive vedolizumab treatment or will be monitored if they received it in an earlier study but aren't continuing treatment. This helps doctors learn more about the medicine's effects over time.

This study is happening in many places around the world and involves young people who have already participated in one of the specific previous vedolizumab studies. By gathering more information from these young people, doctors hope to gain a better understanding of how vedolizumab works safely in children and teenagers with UC or CD.

Key takeaways

This study is about the long-term safety of vedolizumab for young people with UC or Crohn's.
It's only for those who have already participated in specific earlier vedolizumab studies.
Participants will continue to receive vedolizumab infusions every 8 weeks.
The study aims to understand how safe the medicine is over a longer period of time.
Strict contraception rules apply if you are sexually active.
You can discuss your eligibility and specific treatment plan with your doctor.

Who may be eligible?

To join the main treatment part of this study, you must have already taken part in one of two specific previous studies (called MLN0002-3024 or MLN0002-3025). Importantly, you also need to have responded well to the treatment in that earlier study and be able to manage your condition without specific steroid medications by the end of that study.

There are also important rules about contraception for both young men and women. If you are sexually active, you'll need to use reliable birth control methods during the study and for some time afterwards. This is to make sure that no one in the study becomes pregnant, as the effects of the medicine on a developing baby are not fully known.

If you were in an earlier vedolizumab study but don't meet the requirements for continued treatment, you might still be able to join an 'observational' group. This means doctors will simply monitor your health over time without you receiving the study medicine.

Quick self-check

Have I already taken part in study MLN0002-3024 or MLN0002-3025?
Did I respond well to treatment and was I able to reduce steroid use in the earlier study?
Am I using reliable birth control if I am sexually active?
Do I have any planned major surgery for my UC or Crohn's disease soon?
Are there any new, unstable heart, lung, or other serious health problems I've developed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the treatment part of this study, you will continue to receive vedolizumab as an infusion into a vein (IV). This will happen at a dose and frequency similar to what you received near the end of your previous study, typically once every 8 weeks. The exact amount of medicine you receive will depend on your weight. The study medicine will be given 'blinded,' meaning you won't know if you're getting a higher or lower dose, to keep the study fair and unbiased.

Your participation will last until a few things happen: you choose to stop, the medicine becomes widely available for children in your country, other similar support programs start, or the study ends. Throughout this time, you will have regular visits for check-ups and tests. This helps doctors monitor your health and the safety of the medicine. The overall goal is to continue to assess the medication's safety over the long term.

Potential risks and benefits

Taking part in this study could offer the benefit of continuing treatment with vedolizumab if it has been helping manage your ulcerative colitis or Crohn's disease. This might help maintain your well-being and reduce symptoms. As with any medication, there are potential risks, and vedolizumab can have side effects, which you would have learned about in the previous study. The study team will monitor you closely for any new or existing side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (98)

University of South Alabama (USA) Physicians Group
Mobile, United States· Not yet recruiting
Phoenix Childrens Hospital - Thomas Rd - PIN
Phoenix, United States· Recruiting
Cedars Sinai Medical Center - 127 San Vicente Blvd
Los Angeles, United States· Withdrawn
Rady Children's Hospital - San Diego - PIN
San Diego, United States· Not yet recruiting
University of California San Francisco
San Francisco, United States· Withdrawn
I.H.S Health LLC-Kissimmee-445 W Oak St
Kissimmee, United States· Withdrawn
Childrens Center For Digestive Healthcare
Atlanta, United States· Not yet recruiting
Advocate Children's Hospital - Park Ridge - PIN
Park Ridge, United States· Recruiting
Riley Hospital For Children - PIN
Indianapolis, United States· Withdrawn
Johns Hopkins University
Baltimore, United States· Withdrawn
Boston Children's Hospital - PIN
Boston, United States· Withdrawn
MNGI Digestive Health PA-Plymouth
Minneapolis, United States· Terminated

+86 more sites — see the official record for the full list.

Common questions

What is vedolizumab?

Vedolizumab is a medicine used to treat inflammatory bowel diseases like ulcerative colitis and Crohn's disease by targeting specific parts of your immune system that cause inflammation in the gut.

Why is this study only for people who have been in previous studies?

This study is an 'extension' study. It's designed to gather more long-term information about vedolizumab's safety in people who have already started treatment in one of the earlier vedolizumab studies.

Will I know if I'm getting a high or low dose?

No, the dose you receive will be 'blinded,' meaning neither you nor your doctor will know the exact dose during the study. This helps keep the results accurate.

What happens if the medicine becomes available to buy?

If vedolizumab becomes widely available for children in your country, your participation in the study might end, and your doctor can discuss other ways for you to access the medicine.

What is the 'observational cohort'?

This is a group of people who took vedolizumab in a previous study but aren't continuing treatment. They will be monitored by doctors to see how their health progresses over time, without receiving new study medication.

How to find out more

Takeda Contact

medinfoUS@takeda.com +1-877-825-3327 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.