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Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female, ≥18 years of age. 2. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference. 3. 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. 4. New or relapsed GPA or MPA that require treatment with CYC or RTX plus GCs.

Exclusion Criteria:

1. Any other multisystem autoimmune disease 2. Requires mechanical ventilation because of alveolar hemorrhage at Screening. 3. 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. 4. 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(MTX), mycophenolate mofetil (MMF), or mycophenolate sodium (MPS) at the time of Screening, these drugs must be withdrawn prior to receiving CYC or RTX. 5. Received more than 3 g cumulative high dose intravenous GCs within 4 weeks before Screening. 6. On an oral dose of a GC of more than 10 mg prednisone equivalent at Screening or for more than 6 weeks before Screening. 7. 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. 8. Received a live vaccination within 4 weeks before Screening or planned between Screening and Week 24. 9. 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03712345
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

InflaRx GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Korinna Pilz, MD, MSPeter A. Merkel, MD, MPH
Principal Investigator Affiliation InflaRx GmbHUniversity of Pennsylvania
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
Additional Details

Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are related systemic v anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a potentially life-threatening disease. GPA is a necrotizing vasculitis predominantly involving small- to medium-sized vessels (e.g., capillaries, venules, arterioles, arteries, and veins). MPA is a necrotizing vasculitis that primarily affects capillaries, venules, or arterioles, most commonly manifesting as necrotizing glomerulonephritis and/or pulmonary capillaritis. MPA. Primed neutrophils are activated by ANCA and generate C5a that engages C5a receptors on neutrophils. Therefore, patients with ANCA-related disease have elevated plasma and urine levels of C5a in active disease and not in remission. IFX-1 is a monoclonal antibody specifically binding to the soluble human complement split product C5a and the resulting nearly complete blockade of C5a-induced biological effects may be effective in the treatment of subjects with AAV.

Arms & Interventions

Arms

Experimental: Group A

Will receive IFX-1 low dose regimen diluted in sodium chloride solution

Experimental: Group B

Will receive IFX-1 high dose regimen diluted in sodium chloride solution

Placebo Comparator: Group C

Will receive placebo

Interventions

Drug: - IFX-1

Single IV infusions of IFX-1

Drug: - IFX-1

Single IV infusions of IFX-1

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Scottsdale, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259

Loma Linda, California

Status

Recruiting

Address

Loma Linda University Clinical Trial Center

Loma Linda, California, 92354

Science Connections, LLC, Doral, Florida

Status

Recruiting

Address

Science Connections, LLC

Doral, Florida, 33166

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160

LSU Health Sciences Center Shreveport, Shreveport, Louisiana

Status

Recruiting

Address

LSU Health Sciences Center Shreveport

Shreveport, Louisiana, 71103

Johns Hopkins Bayview Medical Center, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

University Of MI Medcl Ctr-RHU, Ann Arbor, Michigan

Status

Recruiting

Address

University Of MI Medcl Ctr-RHU

Ann Arbor, Michigan, 48109

Henry Ford Hospital, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Hospital

Detroit, Michigan, 48084

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55414

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Washington University, Saint Louis, Missouri

Status

Recruiting

Address

Washington University

Saint Louis, Missouri, 63110

University of New Mexico, Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico

Albuquerque, New Mexico, 87131

Northwell Health, LLC PRIME, New Hyde Park, New York

Status

Recruiting

Address

Northwell Health, LLC PRIME

New Hyde Park, New York, 11042

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Rochester, New York

Status

Recruiting

Address

University of Rochester Medical Center - Strong Memorial Hospital

Rochester, New York, 14642

Chapel Hill, North Carolina

Status

Recruiting

Address

UNC Kidney Center, UNC-CH Division of Nephrology and Hypertension

Chapel Hill, North Carolina, 27599-7155

Trinity Medical Group, Minot, North Dakota

Status

Recruiting

Address

Trinity Medical Group

Minot, North Dakota, 58701

Columbus, Ohio

Status

Recruiting

Address

Ohio State University Clinical Trials Management Office

Columbus, Ohio, 43203

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

BRCR Medical Center, Inc., Camp Hill, Pennsylvania

Status

Recruiting

Address

BRCR Medical Center, Inc.

Camp Hill, Pennsylvania, 17011

Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center for Clinical Research, P.C.

Duncansville, Pennsylvania, 16635

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Low Country Rheumatology, PA, North Charleston, South Carolina

Status

Recruiting

Address

Low Country Rheumatology, PA

North Charleston, South Carolina, 29406

Adriana Pop Moody Clinic PA, Corpus Christi, Texas

Status

Recruiting

Address

Adriana Pop Moody Clinic PA

Corpus Christi, Texas, 78404

Texas Health Resources, Dallas, Texas

Status

Recruiting

Address

Texas Health Resources

Dallas, Texas, 75287

Texas Research Institute, Fort Worth, Texas

Status

Recruiting

Address

Texas Research Institute

Fort Worth, Texas, 76104

Pioneer Research Solutions, Inc., Houston, Texas

Status

Recruiting

Address

Pioneer Research Solutions, Inc.

Houston, Texas, 77099

Charlottesville, Virginia

Status

Recruiting

Address

UVA University Physicians Charlottesville

Charlottesville, Virginia, 22903

West Virginia University, Morgantown, West Virginia

Status

Recruiting

Address

West Virginia University

Morgantown, West Virginia, 26506

International Sites

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7

St. Josephs Healthcare, Hamilton, Ontaria, Canada

Status

Recruiting

Address

St. Josephs Healthcare

Hamilton, Ontaria, L8N 4A6

Mount Sinai Hospital, Toronto, Ontario, Canada

Status

Recruiting

Address

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5

CHUM Centre de Recherche, Québec, Quebec, Canada

Status

Recruiting

Address

CHUM Centre de Recherche

Québec, Quebec, H2X 0A9

Centre de Recherche Musculo-Squelettique, Trois-Rivières, Quebec, Canada

Status

Recruiting

Address

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G8Z1Y2