Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405087
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-05-03
Brief Title:
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis UC or Crohns Disease CD
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohns Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508804-39 | OTHER | 2023-508804-39 | None |