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New treatment option for Ulcerative Colitis
Official title A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
ClinicalTrials.gov ID: NCT06405087
What this study is testing
What is Vedolizumab SC?
Vedolizumab SC is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for ulcerative colitis.
Also referred to as MLN0002.
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 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.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was...
- for Observational Cohort
- 1\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic...
You likely can't join if
- for Treatment Cohort
- Has hypersensitivity or allergies to vedolizumab or any of its excipients.
- The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Loma Linda, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Park Ridge, Illinois, United States
- Detroit, Michigan, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Hershey, Pennsylvania, United States
- Charleston, South Carolina, United States
- Tacoma, Washington, United States
- Brussels, Brussels Capital, Belgium
- Liège, Belgium
- Plovdiv, Bulgaria
- Hvidovre, Capital Region, Denmark
- Crumlin, Dublin, Ireland
- Messina, Italy
- Milan, Italy
+ 29 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Loma Linda, California, United States; Orange, California, United States; Palo Alto, California, United States; Park Ridge, Illinois, United States; Detroit, Michigan, United States and 43 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.