A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Conditions

• Crohn's Disease
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab SC — DRUG
  Vedolizumab subcutaneous injection.
• No Intervention — OTHER
  As this is an observational cohort, no intervention will be administered.

Study Details

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.

Key Dates

Start date

Oct 27, 2025

Status verified

Jun 2026

Primary completion

Aug 12, 2030

Completion

Aug 12, 2030

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Cohort: Vedolizumab 108 mg PFS+AI
  Vedolizumab 108 mg, PFS+AI, subcutaneously, once every two weeks (Q2W) to the participants weighing greater than or equal to (\>=) 30 kg and once every four weeks (Q4W) to the participants weighing \>=10 to less than (\<) 30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first.
• Experimental: Treatment Cohort: Vedolizumab 108 mg PFS+NSD
  Vedolizumab 108 mg, PFS+NSD, subcutaneously, Q2W to the participants weighing \>=30 kg and Q4W to the participants weighing \>=10 to \<30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first.
• Other: Observational Cohort: Early Terminated Participants From Parent Study
  Participants who receive any dose of vedolizumab SC during the parent study VedolizumabSC-3003 (NCT06100289) and are not eligible for the treatment cohort of this extension study (that is, participants who early terminated from parent study VedolizumabSC-3003 \[NCT06100289\] or did not achieve clinical response in the parent study or who received corticosteroids in the last 4 weeks of the parent study) will only be observed in the observational cohort of this study and will not receive any dose of the vedolizumab SC in this cohort.

Primary Outcome Measure

Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138) ]

Central Contacts

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

Locations (14)

Find similar trials in Phoenix, AZ

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