IFX: A randomized, double-blind, placebo-controlled, multicenter, parallel-group Phase II study to investigate the safety and efficacy of two different dose regimens of IFX-1

Study Name: IFX-1-P2.6

A randomized, double-blind, placebo-controlled, multicenter, parallel-group Phase II study to investigate the safety and efficacy of two different dose regimens of IFX-1 as add-on to standard of care in subjects with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)

Principal Investigator: Vimal Derebail, MD
Sponsor: InflaRx GmbH
Age Range: 18 years of age and above
Status: Enrolling Fall 2018

Purpose: To learn if the investigational drug IFX-1 added to standard of care (SOC) therapy compared with placebo will be effective in treating patients with active ANCA associated vasculitis.

Study Procedures: IFX-1 will be given via intravenous infusion at weeks 0, 1, 2, 4, 6, 8, 10, 12, 14 and 16 with additional follow-up visits at weeks 20 and 24. Blood and urine will be collected at each study visit along with physical exams and disease activity assessments.

Participation: Participation will last approximately 6 months.

For more information, please contact:

Brenda Meier, RN
Study Coordinator
919-445-2730
brenda_meier@med.unc.edu