Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA

Microscopic Polyangiitis (MPA) Clinical Trial

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

Status Terminated

Clinical Trial Summary

The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with GPA and MPA compared with placebo.

Clinical Trial Description

Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are related systemic v anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a potentially life-threatening disease.

GPA is a necrotizing vasculitis predominantly involving small- to medium-sized vessels (e.g., capillaries, venules, arterioles, arteries, and veins). MPA is a necrotizing vasculitis that primarily affects capillaries, venules, or arterioles, most commonly manifesting as necrotizing glomerulonephritis and/or pulmonary capillaritis. MPA.

Primed neutrophils are activated by ANCA and generate C5a that engages C5a receptors on neutrophils. Therefore, patients with ANCA-related disease have elevated plasma and urine levels of C5a in active disease and not in remission.

IFX-1 is a monoclonal antibody specifically binding to the soluble human complement split product C5a and the resulting nearly complete blockade of C5a-induced biological effects may be effective in the treatment of subjects with AAV. ;

Related Conditions & MeSH terms

• Granulomatosis with Polyangiitis
• Granulomatosis With Polyangiitis (GPA)
• Microscopic Polyangiitis
• Microscopic Polyangiitis (MPA)
• Systemic Vasculitis

• NCT number: NCT03712345
• Study type: Interventional
• Source: InflaRx GmbH
• Status: Terminated
• Phase: Phase 2
• Start date: October 15, 2018
• Completion date: May 3, 2021