Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055959
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-09-20
Brief Title:
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Open-Label Uncontrolled Study to Evaluate the Pharmacokinetics Pharmacodynamics Safety Tolerability and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis
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:
ziMyG
Brief Summary:
The purpose of this study is to assess the pharmacokinetics pharmacodynamics safety tolerability immunogenicity and activity of zilucoplan ZLP in pediatric 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502072-23-00 | REGISTRY | EU CT Number | None |
| U1111-1290-3349 | OTHER | None | None |