Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837897
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2023-04-20
Brief Title:
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohns Disease
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Parallel-Group Double-blind Placebo-Controlled Induction Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Intravenous Vedolizumab 300 mg Infusion Treatment in Subjects in China With Moderately to Severely Active Crohns Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This is a study to evaluate vedolizumab for injection 300 mg as a safe and active treatment for Crohns Disease in adults in China Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0 2 and 6 and starting at week 14 every 8 weeks over 58 weeks or starting at week 18 every 4 weeks over 54 weeks There will be up to 20 study visits over 58 weeks to complete assessments
Detailed Description:
The drug being tested in this study is called vedolizumab Vedolizumab will be administered as an intravenous IV infusion in Chinese participants This study will investigate the efficacy and safety of vedolizumab IV in participants with moderately to severely active Crohns Disease CD
The study will enroll approximately 408 patients Participants will be randomized into 21 in the Induction Period to receive
Vedolizumab IV 300 mg
Placebo
All participants completing the Week 14 visit irrespective of their response status will continue in the OLE without unblinding of their baseline treatment group and will receive 300 mg vedolizumab once every 8 weeks Q8W starting from Week 14 Starting at Week 18 and throughout the remainder of the OLE participants who are nonresponders or who have disease worsening based on the assessment by visit every 4 weeks are eligible to receive 300 mg vedolizumab once every 4 weeks Q4W
This multi-center trial will be conducted in China The overall time participants will be in this study is approximately 58 weeks Participants will make a final safety follow-up visit at 18 weeks after the last dose of study drug Participants will also be followed-up for a long-term follow-up safety survey after completion of or early termination from study via telephone 6 months after last dose of study drug
The study will enroll approximately 408 patients Participants will be randomized into 21 in the Induction Period to receive
Vedolizumab IV 300 mg
Placebo
All participants completing the Week 14 visit irrespective of their response status will continue in the OLE without unblinding of their baseline treatment group and will receive 300 mg vedolizumab once every 8 weeks Q8W starting from Week 14 Starting at Week 18 and throughout the remainder of the OLE participants who are nonresponders or who have disease worsening based on the assessment by visit every 4 weeks are eligible to receive 300 mg vedolizumab once every 4 weeks Q4W
This multi-center trial will be conducted in China The overall time participants will be in this study is approximately 58 weeks Participants will make a final safety follow-up visit at 18 weeks after the last dose of study drug Participants will also be followed-up for a long-term follow-up safety survey after completion of or early termination from study via telephone 6 months after last dose of study drug
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?:
True
Is an FDA AA801 Violation?:
None