Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04643483
Status:
WITHDRAWN
Last Update Posted:
2021-06-23
First Post:
2020-11-19
Brief Title:
A Study to Test Efficacy Safety and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohns Disease
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Multicenter Study Including an Active Reference Arm to Evaluate Efficacy Safety and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents 6 to 17 Years of Age With Moderately to Severely Active Crohns Disease
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03559686
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
The purpose of the study is to assess efficacy safety and tolerability of 2 dose regimens of certolizumab pegol
Detailed Description:
None
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