Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03895801
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2019-03-08
Brief Title:
Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis
Sponsor:
InflaRx GmbH
Organization:
InflaRx GmbH
Study Overview
Official Title:
A Randomized Double-blind Double-dummy Active-controlled Multicenter 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis GPA and Microscopic Polyangiitis MPA
Status:
COMPLETED
Status Verified Date:
2022-08
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:
IXchange
Brief Summary:
The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid GC therapy in subjects with polyangiitis GPA or microscopic polyangiitis MPA
Detailed Description:
Anti-neutrophil cytoplasmic antibody-associated vasculitis AAV is a group of potentially life-threatening autoimmune diseases Preclinical data demonstrate that primed neutrophils are activated by anti-neutrophil cytoplasmic antibody ANCA and generate C5a that engages C5a receptors on neutrophils Patients with ANCA-related disease have elevated plasma and urine levels of C5a in active disease but not in remission IFX-1 is as a monoclonal antibody specifically binding to the soluble human complement split product C5a which results in nearly complete blockade of C5a induced biological effects Therefore IFX-1 may be effective in the treatment of subjects with AAV
In this Phase II study of 20 to 55 subjects with granulomatosis with GPA and MPA IFX-1 will be administered in combination with reduced dose glucocorticoids or a placebo glucocorticoid compared with standard dose glucocorticoids
In this Phase II study of 20 to 55 subjects with granulomatosis with GPA and MPA IFX-1 will be administered in combination with reduced dose glucocorticoids or a placebo glucocorticoid compared with standard dose glucocorticoids
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