Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441682
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
A Safety and Efficacy Study of ARGX-119 in Adult Patients With Amyotrophic Lateral Sclerosis ALS
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
A Phase 2a Double-Blinded Randomized Placebo-Controlled and Active-Treatment Extension Study to Assess the Safety Tolerability Efficacy Pharmacokinetics and Immunogenicity of ARGX-119 in Participants With Amyotrophic Lateral Sclerosis
Status:
NOT_YET_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:
ReALiSe
Brief Summary:
This study aims to evaluate the safety of ARGX-119 in adults with ALS The study will also assess the impact of ARGX-119 on ALS disease outcomes including muscle function The study consists of 2 periods a treatment period when participants will receive one of three ARGX-119 doses or placebo and an extension period when all participants will receive the same dose of ARGX-119 Participation in the study will last up to approximately 100 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 2024-511318-19-00 | CTIS | None | None |