A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Has hypersensitivity or allergies to vedolizumab or any of its excipients.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Vedolizumab SC
DrugVedolizumab subcutaneous injection.
No Intervention
Other interventionAs this is an observational cohort, no intervention will be administered.
Treatment groups
70 Participants
are divided into 3 treatment groupsGroup A: Treatment Cohort: Vedolizumab 108 mg PFS+AIExperimental treatment 1 intervention
Group B: Treatment Cohort: Vedolizumab 108 mg PFS+NSDExperimental treatment 1 intervention
Group C: Observational Cohort: Early Terminated Participants From Parent StudyOther 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame
First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)2
Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs)
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.
Time frame
First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)3
Observational Cohort: Number of Participants With Prespecified Safety Events
Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery.
Time frame
Up to Week 86Secondary outcomes
1
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
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.
Time frame
Up to Week 1202
Treatment Cohort: Change from Baseline in IMPACT-III Scores
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).
Time frame
Baseline, every 24 weeks in this study (up to Week 120) Source ClinicalTrials.gov