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

Phase 3

Not yet recruiting

• Conditions: Ulcerative Colitis; Crohn's Disease
• Interventions: Drug: Vedolizumab SC; Other: No Intervention

• Registration Number: NCT06405087
• Lead Sponsor: Takeda

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Study Start: 2024-12-02
• Primary Completion: 2032-01-26
• Study Completion: 2032-01-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Cohort: Vedolizumab 108 mg PFS+AI	Vedolizumab SC	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.
Treatment Cohort: Vedolizumab 108 mg PFS+NSD	Vedolizumab SC	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.
Observational Cohort: Early Terminated Participants From Parent Study	No Intervention	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 Measures

Name	Time	Method
Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)	An Adverse event (AE) is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with use of drug whether or not it is considered related to drug. SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening.
Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs)	First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)	AESI is defined as infections, including opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions.
Observational Cohort: Number of Participants With Prespecified Safety Events	Up to Week 86	Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery.

Secondary Outcome Measures

Name	Time	Method
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events	Up to Week 120	Time to major IBD related events is defined as time to first occurrence of any among the 3 IBD related events such as: hospitalizations, surgeries, and procedures.
Treatment Cohort: Change from Baseline in IMPACT-III Scores	Baseline, every 24 weeks in this study (up to Week 120)	IMPACT-III questionnaire will be administered to participants aged 9 to 17 years. The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert subscale score ranging from 1 to 5 for all answers. The outcome total score ranges from 35 to 175, with higher scores suggesting better quality of life. Baseline refers to the Baseline of study VedolizumabSC-3003 (NCT06100289).