Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05918978
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-06-22
Brief Title:
Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of Efgartigimod in Adult Patients With Post-COVID-19 Postural Orthostatic Tachycardia Syndrome PC-POTS Who Completed Study ARGX-113-2104
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
POTS
Brief Summary:
The OLE study aims to investigate the safety efficacy pharmacodynamics PD pharmacokinetics PK and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic
Detailed Description:
Study ARGX-113-2105 is a long-term single-arm open-label multicenter extension of the ARGX-113-2104 study designed to evaluate the long-term safety of efgartigimod IV in adult patients with PC-POTS Participants will be enrolled from both active and placebo arms of the ARGX-113-2104 study and will receive efgartigimod IV 10 mgkg in the extension study without knowledge of their prior treatment arm To be eligible to enroll in this study participants must have completed the 24-week treatment period of the ARGX-113-2104 study and must not have permanently discontinued the IMP in that study
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