349  0 Kommentare InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients

• Multi-national, randomized, controlled adaptive Phase III design for vilobelimab in ulcerative pyoderma gangrenosum (PG)
• Trial size to be adapted upon interim analysis with planned total patient number between approximately 50 and 100 patients
• FDA review of application for emergency use authorization (EUA) of vilobelimab for the treatment of critically ill COVID-19 patients ongoing
• InflaRx’s management team to host investor and business meetings during JPM Week, January 9 – 12, 2023 in San Francisco, California

JENA, Germany, Jan. 05, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced details related to the design of its planned Phase III study with vilobelimab in ulcerative PG, a rare neutrophilic and inflammatory skin disease with destructive, painful cutaneous ulcers.

The planned Phase III study is designed to enroll patients in the US, Europe and selected countries in other regions. The enrollment period is projected to be at least two years, depending on the total trial size after sample size adaptation. The design is based on detailed feedback and recommendations from the FDA Division of Dermatology and Dentistry and was developed in close collaboration with the Company´s advisors from the US, Europe and other regions.

The multi-national, randomized, double-blind, placebo-controlled Phase III trial will have two arms: vilobelimab (2400mg every other week) plus a low dose of corticosteroids and placebo plus the same low dose of corticosteroids. In both arms, corticosteroid treatment will be initiated on day 1 and will be tapered off within the first 8 weeks of the trial. The primary endpoint of the study will be complete closure of the target ulcer at any time up to 26 weeks after initiation of treatment. Treatment will be discontinued for patients whose disease progresses or fails to improve at defined time points during the study.

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The study has an adaptive trial design with an interim analysis blinded for the sponsor and investigators (but unblinded for the independent data safety monitoring committee) planned upon enrollment of approximately 30 patients (15 per arm). The interim analysis with a set of predefined rules will take into account the then-observed difference in complete target ulcer closure between the two arms and, accordingly, the trial sample size will be adapted or the trial will be stopped due to futility.