Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02665364
Status:
TERMINATED
Last Update Posted:
2020-04-09
First Post:
2015-11-17
Brief Title:
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
Sponsor:
Neovacs
Organization:
Neovacs
Study Overview
Official Title:
A Phase IIb Randomized Double-Blind Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reorganization proceedings of the sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The safety and immunogenicity of the IFNα-Kinoid IFN-K have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus SLE Preliminary results showed acceptable safety profile and patients developped antibodies response
The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE In addition the immune responses and the safety elicited by IFN-K will also be evaluated
The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE In addition the immune responses and the safety elicited by IFN-K will also be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None