Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

Summary

The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.

Timeline

Start

2019-05-16

Primary completion

2022-01-03

Completion

2022-01-03

Outcome

Met primary endpoint

release “announces positive initial data from the first 5 patients in the Phase IIa open label study with IFX-1 in patients suffering from Pyoderma Gangraenosum (PG).” reads as unknown inflarx.de ↗

release “Out of the first 5 initial patients dosed with IFX-1, 2 patients achieved complete closure of the target ulcer.” reads as unknown inflarx.de ↗

release “Six of the seven patients achieved clinical remission with a PGA score of ≤1, which reflects a closure of the target ulcer.” reads as met primary endpoint inflarx.de ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	vilobelimab	Monoclonal antibody	800 mg	Intravenous
Subject	vilobelimab	Monoclonal antibody	1600 mg	Intravenous
Subject	vilobelimab	Monoclonal antibody	2400 mg	Intravenous

Indications