Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436742
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-21
Brief Title:
A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants with DOK7-Congenital Myasthenic Syndromes CMS
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
A Phase 1b Double-Blinded Randomized Placebo-Controlled Study to Assess the Safety Tolerability Pharmacokinetics Immunogenicity and Efficacy of ARGX-119 in Adult Participants with DOK7-Congenital Myasthenic Syndromes
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:
None
Brief Summary:
The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes The study will also assess how ARGX-119 is processed by the body pharmacokinetics how the immune system reacts to it immunogenicity and how it may improve the way patients feel and function
After the screening period eligible participants will be randomized in a 41 ratio to receive intravenous infusions of ARGX-119 or placebo during the treatment period Participants will then enter the follow-up period The full duration of the study is approximately 11 months
After the screening period eligible participants will be randomized in a 41 ratio to receive intravenous infusions of ARGX-119 or placebo during the treatment period Participants will then enter the follow-up period The full duration of the study is approximately 11 months
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 |
|---|---|---|---|
| 2023-509872-41-00 | CTIS | None | None |