A Study of Vedolizumab in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Ulcerative Colitis, Crohn's Disease
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- The participant 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.
- A male participant who is sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (eg, condom with or without spermicide) from signing of informed consent 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 informed consent throughout the duration of the study and 18 weeks after the last dose.
Exclusion Criteria:
- 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.
Sites / Locations
- The Children's Hospital Zhejiang UniversitySchool of MedicineRecruiting
- Children's Hospital "Agia Sofia"Recruiting
- Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato KorhazRecruiting
- Sapienza University of RomeRecruiting
- Kyungpook National University Chilgok hospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Samsung Medical Center - PPDSRecruiting
- Instytut Pomnik Centrum Zdrowia DzieckaRecruiting
- Korczowski Bartosz, Gabinet LekarskiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Other
Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg
Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg
Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg
Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg
Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg
Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg
Observational Cohort: Early Terminated Participants From Parent Studies
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 until participant withdrawal, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first.
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 until participant withdrawal, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first.
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 until participant withdrawal, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first.
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 until participant withdrawal, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first.
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 until participant withdrawal, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first.
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 until participant withdrawal, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first.
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.