Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05732402
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-02-08
Brief Title:
An Open-label Study of Povetacicept ALPN-303 in Autoimmune Kidney Diseases
Sponsor:
Alpine Immune Sciences Inc
Organization:
Alpine Immune Sciences Inc
Study Overview
Official Title:
An Open-Label Multiple-Ascending Dose Study to Assess the Safety Efficacy Pharmacokinetics and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects With Autoantibody-Associated Glomerular Diseases RUBY-3
Status:
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:
RUBY-3
Brief Summary:
The goal of this clinical study is to evaluate multiple dose levels of povetacicept ALPN-303 in adults with immunoglobulin A IgA nephropathy membranous nephropathy lupus-related kidney disease lupus nephritis or anti-neutrophil cytoplasmic antibody ANCA associated vasculitis to determine if povetacicept is safe and potentially beneficial in treating these diseases
During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months with the possibility of participating in a 6-month treatment extension period and an optional 52 week treatment extension period
During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months with the possibility of participating in a 6-month treatment extension period and an optional 52 week treatment extension period
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