Trials / Terminated
TerminatedNCT03712345
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- InflaRx GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IFX-1 low dose | Single IV infusions of IFX-1 |
| DRUG | IFX-1 high dose | Single IV infusions of IFX-1 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2018-10-15
- Primary completion
- 2020-09-10
- Completion
- 2021-05-03
- First posted
- 2018-10-19
- Last updated
- 2022-05-26
- Results posted
- 2022-05-26
Locations
38 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03712345. Inclusion in this directory is not an endorsement.