Therapy Areas: Inflammatory Diseases
InflaRx initiates Phase III trial for vilobelimab in ulcerative pyoderma gangrenosum
6 November 2023 -

InflaRx N.V. (Nasdaq:IFRX), a developer of anti-inflammatory therapeutics, announced on Monday that the first patient has been dosed in its Phase III study examining the efficacy and safety of vilobelimab in treating ulcerative pyoderma gangrenosum (PG), a rare autoimmune skin disease characterised by destructive, painful cutaneous ulcers.

This multinational trial aims to recruit patients globally, including in the United States, Europe and Australia. This randomised, double-blind, placebo-controlled study features two arms: one receiving vilobelimab (2400mg every other week) combined with a low corticosteroid dose, and the other getting a placebo along with the same low corticosteroid dose. In both arms, corticosteroid treatment will commence on day 1 and taper over the initial 8 weeks. The primary endpoint is complete target ulcer closure within 26 weeks of treatment initiation.

The trial employs an adaptive design, with an interim analysis conducted by an independent data safety monitoring committee after enrolling about 30 patients, evenly distributed between the two arms. This analysis, based on predefined rules, will assess the difference in complete target ulcer closure between the arms and determine potential adjustments to the trial's sample size or its termination due to futility. The enrolment phase is anticipated to extend for at least two years, depending on the overall trial size after sample size adaptation.

InflaRx has been granted Fast Track and Orphan Drug designations by the US FDA, as well as Orphan Drug designation by the European Medicines Agency, for the treatment of PG.