NCT03971643

Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

Open Label Exploratory Phase IIa Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Patients With Pyoderma Gangrenosum (OPTIMA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: InflaRx GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Neutrophilic dermatoses are a spectrum of inflammatory disorders characterized by skin lesions resulting from a neutrophil-rich inflammatory infiltrate in the absence of infection. Pyoderma gangrenosum is associated with a neutrophilic leukocytosis, which is likely to be triggered by C5a. This study is set up based on the hypothesis that vilobelimab might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.

Conditions

• Pyoderma Gangrenosum

Interventions

Type	Name	Description
DRUG	vilobelimab	IV infusions of vilobelimab diluted in sodium chloride.

Timeline

• Start date: 2019-05-16
• Primary completion: 2022-01-03
• Completion: 2022-01-03
• First posted: 2019-06-03
• Last updated: 2023-09-14
• Results posted: 2023-09-14

Locations

10 sites across 3 countries: United States, Canada, Poland

Regulatory

• FDA-regulated drug study