Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05514873
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-08-22
Brief Title:
An Open-label Study to Evaluate the Safety Tolerability and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Phase 3b Multicenter Open-Label Single-Arm Study to Evaluate the Safety Tolerability and Efficacy of Zilucoplan in Participants With Generalized Myasthenia Gravis Switching From Intravenous Complement Component 5 Inhibitors to Subcutaneous Zilucoplan
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 purpose of the study is to evaluate the safety and tolerability of switching from intravenous IV complement component 5 C5 inhibitors to subcutaneous SC Zilucoplan in study participants with generalized myasthenia gravis gMG
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?:
None
Is an FDA AA801 Violation?:
None