Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05757570
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-02-24
Brief Title:
An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias
Sponsor:
Alpine Immune Sciences Inc
Organization:
Alpine Immune Sciences Inc
Study Overview
Official Title:
Open-Label Study to Assess the Safety Efficacy Pharmacokinetics and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias RUBY-4
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-4
Brief Summary:
The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia autoimmune hemolytic anemia and cold agglutinin disease 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 study 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