Vedolizumab for Ulcerative Colitis
Trial Summary
What is the purpose of this trial?
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be unresponsive or intolerant to their current standard of care, which might imply changes to your medication routine. It's best to discuss this with the trial coordinators.
What data supports the effectiveness of the drug Vedolizumab for treating ulcerative colitis?
Vedolizumab has been shown to be effective for treating moderate to severe ulcerative colitis, with clinical trials indicating higher rates of clinical response and remission compared to a placebo. It is specifically designed to target inflammation in the gut, making it a useful option for patients who have not responded well to other treatments.12345
Is Vedolizumab safe for humans?
How does the drug Vedolizumab differ from other treatments for ulcerative colitis?
Vedolizumab is unique because it specifically targets the α4β7 integrin, which helps prevent immune cells from reaching the gut and causing inflammation, making it gut-specific and reducing the risk of certain side effects seen with other treatments. This mechanism is different from other drugs like anti-TNF agents, which can affect the entire immune system.12345
Eligibility Criteria
This trial is for children and teenagers weighing at least 10 kg with moderate to severe ulcerative colitis diagnosed over a month ago. They must have tried treatments like corticosteroids or TNF-α antagonists without success, or cannot tolerate them. Participants should not have had certain surgeries, live vaccines recently, other biologic treatments too close to the study start, active infections including TB or hepatitis B/C, or any history of neurological disorders.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline
Maintenance
Participants who achieve clinical response receive vedolizumab IV infusions every 8 weeks up to Week 46
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants enter an observational long-term follow-up period of 2 years after the last dose of study drug
Treatment Details
Interventions
- Vedolizumab
Vedolizumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Ulcerative colitis
- Crohn's disease
- Ulcerative colitis
- Crohn's disease
- Ulcerative colitis
- Crohn's disease
- Ulcerative colitis
- Crohn's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier