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Looking for participantsPhase3

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

Sponsor: Takeda

NCT ID: NCT05442567

View on ClinicalTrials.gov ↗

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.

Ulcerative ColitisCrohn's Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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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
Main Inclusion Criteria: For Treatment Cohort: 1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30. 2. A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception. 3. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose. For Observational Cohort: 1\. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study. Main Exclusion Criteria: For Treatment Cohort only: 1. The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study. 2. The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety. 3. The participant has other serious comorbidities that will limit their ability to complete the study. 4. The participant is unable to comply with all study assessments. 5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients. 6. The participant is lactating or pregnant.

Where Is This Study? (6 UK sites)

Great Ormond Street Hospital

London WC1N 3AJ, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

Noahs Ark Childrens Hospital for Wales - PIN

Cardiff CF14 4XW, United Kingdom

WITHDRAWN

King's College Hospital

London SE5 9RS, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Birmingham Women's and Children's NHS Foundation Trust

Birmingham B4 6NH, United Kingdom

Recruiting
Site contact (verified)
Rafeeq MuhammedPrincipal Investigator

Barts Health NHS Trust - PPDS

London E1 1BB, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Sandhia NaikPrincipal Investigator

Royal Manchester Children's Hospital - PPDS - PIN

Manchester M27 4HA, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

How to Get in Touch

Takeda Contact

Sponsor contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05