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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)

In brief

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.

Key facts

Study ID

NCT03712345

Run by

InflaRx GmbH

People needed

20

Starts

2018-10-15

Expected to finish

2021-05-03

Last updated by the study team

2022-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, ≥18 years of age.
• Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference.
• Have at least one "major" item, or at least three other items, or at least two renal items on the Birmingham Vasculitis Activity Score (BVAS) Version 3.0.
• New or relapsed GPA or MPA that require treatment with CYC or RTX plus GCs.

You may not qualify if…

• Any other multisystem autoimmune disease
• Requires mechanical ventilation because of alveolar hemorrhage at Screening.
• Human immunodeficiency virus, hepatitis B, or hepatitis C viral screening test showing evidence of active or chronic viral infection at Screening or a documented history of the human immunodeficiency virus, hepatitis B, or hepatitis C.
• Received CYC or RTX 12 weeks before Screening; if on azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or mycophenolate sodium (MPS) at the time of Screening, these drugs must be withdrawn prior to receiving CYC or RTX.
• Received more than 3 g cumulative high dose intravenous GCs within 4 weeks before Screening.
• On an oral dose of a GC of more than 10 mg prednisone equivalent at Screening or for more than 6 weeks before Screening.
• Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin or plasma exchange, antithymocyte globulin, or required dialysis within 12 weeks before Screening.
• Received a live vaccination within 4 weeks before Screening or planned between Screening and Week 24.
• Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception (pearl index <1%) such as complete sexual abstinence, combined oral contraceptive, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant, or depot contraceptive injection in combination with a second method of contraception such as condom, cervical cap, or diaphragm with spermicide during the study and for at least 4 weeks after last administration of IFX-1 (timeframes for SOC have to be considered as described in the respective Prescribing Information).

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Loma Linda University Clinical Trial Center — Loma Linda, California, United States
• Science Connections, LLC — Doral, Florida, United States
• University of Miami — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• LSU Health Sciences Center Shreveport — Shreveport, Louisiana, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University Of MI Medcl Ctr-RHU — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Northwell Health, LLC PRIME — New Hyde Park, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• University of Rochester Medical Center - Strong Memorial Hospital — Rochester, New York, United States
• UNC Kidney Center, UNC-CH Division of Nephrology and Hypertension — Chapel Hill, North Carolina, United States
• Trinity Medical Group — Minot, North Dakota, United States
• Ohio State University Clinical Trials Management Office — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• BRCR Medical Center, Inc. — Camp Hill, Pennsylvania, United States
• Altoona Center for Clinical Research, P.C. — Duncansville, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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