NCT03487276

Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: InflaRx GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

Detailed description

Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in apocrine glands. HS is diagnosed by its clinical features and its chronicity. It is recognized by the presence of recurrent, painful, deep-seated, rounded nodules usually ending in abscesses and sinus tracts with suppuration and hypertrophic scarring. As complement C5a is involved in the underlying acute inflammatory responses, this study is set up based on the hypothesis that IFX-1 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

• Hidradenitis Suppurativa (HS)

Interventions

Type	Name	Description
DRUG	IFX-1	Single IV infusions of IFX-1 diluted in sodium chloride.
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-02-26
• Primary completion: 2019-05-27
• Completion: 2020-01-27
• First posted: 2018-04-04
• Last updated: 2021-04-08
• Results posted: 2021-04-08

Locations

41 sites across 9 countries: United States, Bulgaria, Canada, Denmark, France, Germany, Greece, Netherlands, Poland

Regulatory

• FDA-regulated drug study