Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392386
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-04-26
Brief Title:
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age with Generalized Myasthenia Gravis
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
An Open-label Uncontrolled Study to Evaluate the Pharmacokinetics Pharmacodynamics Safety and Activity of Efgartigimod PH20 SC in Participants from 2 to Less Than 18 Years of Age with 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:
ADAPT Jr SC
Brief Summary:
The purpose of this study is to measure the pharmacokinetics PK pharmacodynamics PD safety tolerability and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to 18 years The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study At the end of the follow-up period eligible participants may roll over to an open-label extension OLE study
The participants will be in the study for up to 14 weeks
The participants will be in the study for up to 14 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506159-12-00 | CTIS | None | None |