Microscopic Polyangiitis (MPA) Clinical Trial
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)
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).
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03920722 -
Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis
|
Phase 3 | |
| Terminated |
NCT03712345 -
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
|
Phase 2 | |
| Recruiting |
NCT02593565 -
Vasculitis Pregnancy Registry
|
||
| Completed |
NCT03919825 -
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - Glucocorticoids
|
Phase 3 | |
| Completed |
NCT00987389 -
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
|
Phase 3 | |
| Completed |
NCT02507024 -
The ANCA Vasculitis Questionnaire (AAV-PRO©)
|
N/A | |
| Recruiting |
NCT03004326 -
Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
|