Ignite Creation Date:
2024-05-06 @ 2:28 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04322149
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2020-03-20
Brief Title:
Multiple Doses of AT-1501-A201 in Adults With ALS
Sponsor:
Anelixis Therapeutics LLC
Organization:
Eledon Pharmaceuticals
Study Overview
Official Title:
A Phase 2a Open-Label Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults With ALS
Status:
COMPLETED
Status Verified Date:
2023-06
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:
This is a Phase 2a multi-center open label multiple dose study of AT-1501 a humanized monoclonal antibody antagonist to CD40 ligand CD40L Approximately 54 adults with Amyotrophic Lateral Sclerosis ALS will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites
Participants will be enrolled into one of four ascending doses
Participants will be enrolled into one of four ascending doses
Detailed Description:
This is a Phase 2a multi-center open label multiple dose study of AT-1501 a humanized monoclonal antibody antagonist to CD40L Approximately 54 adults with ALS will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites
Four ascending doses of AT-1501 will be administered as an IV infusion to sequentially enrolling cohorts Each participant will receive 6 bi-weekly every other week infusions of AT-1501 over an 11-week period
The study is estimated to take 19 weeks for participants
Four ascending doses of AT-1501 will be administered as an IV infusion to sequentially enrolling cohorts Each participant will receive 6 bi-weekly every other week infusions of AT-1501 over an 11-week period
The study is estimated to take 19 weeks for participants
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