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Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.

NCT03895801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2022-08-25

Study results available
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Summary

The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Conditions

  • Granulomatosis With Polyangiitis (GPA)
  • Microscopic Polyangiitis (MPA)

Interventions

DRUG

IFX-1

intravenously administered

DRUG

Placebo-IFX-1

intravenously administered

DRUG

Glucocorticoid (GC)

orally administered

DRUG

Placebo-Glucocorticoid (Placebo-GC)

orally administered

Sponsors & Collaborators

  • InflaRx GmbH

    lead INDUSTRY

Principal Investigators

  • Anja Pfaff, PhD · InflaRx GmbH

  • Peter A. Merkel, MD, MPH · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2021-04-14
Completion
2021-06-08
FDA Drug
Yes

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895801 on ClinicalTrials.gov