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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405087
• Other study ID #: VedolizumabSC-3004
• Secondary ID: EU CT Number
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2, 2024
• Est. completion date: January 26, 2032

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 receive vedolizumab SC injection on Day 1 based on their weight as:

• Participants with greater than or equal to (>=) 30 kilogram (kg) weight, Vedolizumab 108 milligram (mg) once every two weeks (Q2W)

• Participants with >= 10 kg to less than (<) 30 kg weight, Vedolizumab 108 mg once every four weeks (Q4W)

This multi-center trial will be conducted globally. The overall time to participate in this study is up to 5 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: January 26, 2032
• Est. primary completion date: January 26, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Vedolizumab SC
Vedolizumab subcutaneous injection.

Other:
• No Intervention
As this is an observational cohort, no intervention will be administered.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 282)
Primary	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.	First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 282)
Primary	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.	Up to Week 86
Secondary	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.	Up to Week 264
Secondary	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).	Baseline, every 24 weeks in this study (up to Week 264)

External Links

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