Ignite Creation Date:
2024-05-05 @ 10:11 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01058343
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2010-01-27
Brief Title:
Safety of IFNa Kinoid in Systemic Lupus Erythematosus
Sponsor:
Neovacs
Organization:
Neovacs
Study Overview
Official Title:
A Phase I-II Randomized Double-blind Placebo-controlled Dose Escalation Study of Neovacs IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2019-03
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:
Interferon alpha IFNa is involved in the pathogenesis of systemic lupus erythematosus SLEand IFNa levels are associated with the severity of the disease Blocking IFNa could be an attractive therapeutic strategy Active immunization with IFNa kinoid IFN-K induces a polyclonal antibody response
This study will evaluate the safety of IFN-K in patients with mild to moderate SLE It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease
This study will evaluate the safety of IFN-K in patients with mild to moderate SLE It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease
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