At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Vedolizumab IV (drug), No Intervention (other)
- How long the study runs
- Study runs about 117 months (dates as stated)
- About the drug or intervention
- Vedolizumab IV — drug: Vedolizumab IV infusion · No Intervention — other: Participants will not receive any intervention in the Observational Cohort.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 2 Years and over
- Who
- All
- Number of participants
- 240
- Started
- 2023-05-16
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for ulcerative colitis
- • Phase3 - 240 participants
- • The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\])
Who can take part?
- • Ages 2 Years and over
- • Diagnosed with ulcerative colitis
Where?
- • London - Great Ormond Street Hospital
- • Cardiff - Noahs Ark Childrens Hospital for Wales - PIN
- • London - King's College Hospital
- • Birmingham - Birmingham Women's and Children's NHS Foundation Trust
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
More detail
This multi-center trial is conducted worldwide. Up to 240 patients would be enrolled from Studies MLN0002-3024 \[participants with UC\] and MLN0002-3025 \[participants with CD\], either in the Treatment Cohort or in the Observational Cohort. Approximately 93 participants who have previously participated either in study MLN0002-3024 or MLN0002-3025, referred to as parent study, are expected to roll over to the MLN0002-3029 study in the treatment cohort. Treatment Cohort: The drug being tested in this study is called vedolizumab, being studied to treat pediatric patients who have UC or CD. Participants eligible for the Treatment Cohort can be administered vedolizumab intravenous (IV) at Week 54 visit of parent study or up to 1 week after Week 54 of the parent study based on the availability of test results needed to assess eligibility of the participant. At this study entry, participants will be administered the same blinded dose of vedolizumab IV that was received at Week 46 in the parent study and will then continue to receive vedolizumab IV at a frequency of once every 8 weeks (Q8W) in the following treatment groups: * Participants 10 to ≤15 kilogram (kg), Vedolizumab 150 milligram (mg) (High dose) * Participants 10 to ≤15 kg, Vedolizumab 100 mg (Low dose) * Participants \>15 to \<30 kg, Vedolizumab 200 mg (High dose) * Participants \>15 to \<30 kg, Vedolizumab 100 mg (Low dose) * Participants ≥30 kg, Vedolizumab 300 mg (High dose) * Participants ≥30 kg, Vedolizumab 150 mg (Low dose) Blinding of dose group assignment of the parent study will continue until the respective parent study is unblinded in order to protect the blinding of the parent study. The overall time to participate in the Treatment Cohort of this study is up to participant withdrawal, or until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first. Participants who complete or are discontinued from the study for any reason will complete the final safety/end of study (EOS) visit 18 weeks after their last dose of study drug. Observational Cohort: Participants who received at least 1 dose of study drug during parent study and early terminated or are not eligible for the Treatment Cohort of this study after completion of the Week 54 visit of parent study, will be enrolled in the Observational Cohort of this study as part of a long-term follow-up period to assess prespecified safety events of interest and will not receive continued treatment with vedolizumab IV. The overall time to participate in the Observational Cohort is up to approximately 2 years.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years and over
- Who can join: All genders
What the study is looking for
- ✓For Treatment Cohort:
- ✓For Observational Cohort:
Who cannot take part
- ✗For Treatment Cohort only:
- ✗The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is...
- ✗The participant has other serious other health conditions 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.
See the full criteria
Where Is This Study? (6 UK sites)
Great Ormond Street Hospital
London WC1N 3AJ, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Noahs Ark Childrens Hospital for Wales - PIN
Cardiff CF14 4XW, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham B4 6NH, United Kingdom
Barts Health NHS Trust - PPDS
London E1 1BB, United Kingdom
Royal Manchester Children's Hospital - PPDS - PIN
Manchester M27 4HA, United Kingdom
How to Get in Touch
Takeda Contact
Sponsor contactCONTACT
