MedTrace Logo

Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA

NCT03712345 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-26

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with GPA and MPA compared with placebo.

Conditions

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

Interventions

DRUG

IFX-1 low dose

Single IV infusions of IFX-1

DRUG

IFX-1 high dose

Single IV infusions of IFX-1

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • InflaRx GmbH

    lead INDUSTRY

Principal Investigators

  • Korinna Pilz, MD, MS · InflaRx GmbH

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-09-10
Completion
2021-05-03
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT03712345 on ClinicalTrials.gov