Clinical trial NCT06405087: A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Official title: A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-05-08
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The drug being tested in this study is Vedolizumab SC. Vedolizumab SC is being tested to treat pediatric participants with moderate to severe active UC or CD. This study will look at the long-term safety profile in pediatric participants who take vedolizumab SC.

The study will enroll approximately 70 participants. This extension study consists of a treatment cohort and an observational cohort. Participants will continue receiving the same dose and frequency of vedolizumab SC that was received at the last dose of the parent study VedolizumabSC-3003 (NCT06100289).

For the Treatment cohort participants will be randomized (1:1) to receive vedolizumab in either a prefilled syringe (PFS) as part of an autoinjector pen (PFS+AI) or a PFS with a needle safety device (PFS+NSD):

* Treatment Cohort: Vedolizumab 108 milligram (mg) PFS+AI
* Treatment Cohort: Vedolizumab 108 mg PFS+NSD

This multi-center trial will be conducted globally. The overall time to participate in this study is up to 2 years from the first dose in the study. Participants in the treatment cohort will have a follow-up safety visit of 18 weeks after their last dose of study drug. Participants who will not be eligible for the treatment cohort will be enrolled in the observational cohort and will be followed for approximately 2 years after the last dose of vedolizumab SC received during Study VedolizumabSC-3003 (NCT06100289).

Eligibility criteria: Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of \>=2 points and \>= 25 percentage (%) from baseline (from VedolizumabSC-3003 \[NCT06100289\]), including a \>=1-point decrease in the Mayo stool frequency subscore and a \>=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (\<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) \<=30 with a reduction in the PCDAI of \>=15 points from baseline (from VedolizumabSC-3003 \[NCT06100289\]).

Inclusion Criteria for Observational Cohort

1. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.

Exclusion Criteria for Treatment Cohort

1. Has hypersensitivity or allergies to vedolizumab or any of its excipients.
2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.

Primary outcomes:
measure: Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
measure: Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs)
timeFrame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
measure: Observational Cohort: Number of Participants With Prespecified Safety Events
timeFrame: Up to Week 86
Secondary outcomes:
measure: Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
timeFrame: Up to Week 120
measure: Treatment Cohort: Change from Baseline in IMPACT-III Scores
timeFrame: Baseline, every 24 weeks in this study (up to Week 120)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: