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Taking people in ItalyPhase 3

Long-term safety of vedolizumab in children with ulcerative colitis or Crohn's disease

Checks long-term safety of vedolizumab infusions in children with bowel inflammation.

Key facts

Who runs it
Takeda
Where
Bologna, Florence, Monza, Naples, and Rome, ItalySee the 6 sitesAlso in 17 other countries, 84 sites
Registry title
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Status
Recruiting
Phase
Phase 3
People taking part
240 people, planned
Started
16 May 2023
Expected to end
7 Feb 2033
Type of study
Interventional, 7 groups
Treatments tested
  • Vedolizumab IV
Record updated
7 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers who already took part in one of two earlier vedolizumab studies for ulcerative colitis or Crohn's disease. It checks the long-term safety of vedolizumab.

Age
2 Years to 17 Years
Sex
All sexes can join.
Disease stage
Ulcerative colitis or Crohn's disease. For the treatment group, the earlier study must have ended with a clinical response without steroids at Week 54.
Earlier treatment
Must have completed or taken part in study MLN0002-3024 or MLN0002-3025. The observational group must have had at least 1 dose of vedolizumab in one of those studies.

Main reasons for not taking part

  • Needs or is expected to need major surgery for UC or CD during the study (treatment group)
  • New unstable or uncontrolled serious medical condition (treatment group)
  • Allergy to any of the vedolizumab excipients (treatment group)
  • Pregnant or breastfeeding (treatment group)
  • Cannot complete all study assessments (treatment group)

The registry criteria, word for word

Show all 12 criteriaShow less

Other criteria

  • Main Inclusion Criteria:
  • For Treatment Cohort:
  • 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
  • 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
  • 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:
  • 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:
  • 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
  • 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
  • The participant has other serious comorbidities 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
  • The participant is lactating or pregnant

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 17 years old?

Where in Italy

Also in 17 other countries, 84 sites

  • Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
  • Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
  • Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
  • Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people

About the trial

What the trial wants to find out

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.

The 7 groups in the trial

  • Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mgTreatment being tested

    Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

    Treatment: Vedolizumab IV

  • Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mgTreatment being tested

    Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

    Treatment: Vedolizumab IV

  • Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mgTreatment being tested

    Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

    Treatment: Vedolizumab IV

  • Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mgTreatment being tested

    Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

    Treatment: Vedolizumab IV

  • Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mgTreatment being tested

    Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

    Treatment: Vedolizumab IV

  • Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mgTreatment being tested

    Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

    Treatment: Vedolizumab IV

  • Observational Cohort: Early Terminated Participants From Parent StudiesOther group

    Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
Plain-language title
Long-term safety of vedolizumab in children with ulcerative colitis or Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05442567, who can take part
Record updated
7 May 2026