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