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

Conditions

• Crohn's Disease
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab IV — DRUG
  Vedolizumab IV infusion
• No Intervention — OTHER
  Participants will not receive any intervention in the Observational Cohort.

Study Details

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.

Key Dates

Start date

May 16, 2023

Status verified

May 2026

Primary completion

Feb 7, 2033

Completion

Feb 7, 2033

Study Design

Enrollment

240 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg
  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.
• Experimental: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg
  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.
• Experimental: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg
  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.
• Experimental: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg
  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.
• Experimental: Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg
  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.
• Experimental: Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg
  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.
• Other: Observational Cohort: Early Terminated Participants From Parent Studies
  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.

Primary Outcome Measure

Treatment Cohort: Number of Participants With at Least One Adverse Event (AE) [ Time Frame: From first dose of study drug up to approximately 5 years ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (22)

Find similar trials in Mobile, AL

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