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

NCT03712345 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IFX-1-P2.6
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 38

Brief 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)

Keywords

Granulomatosis with Polyangiitis (GPA); Microscopic Polyangiitis (MPA); IFX-1; ANCA; AAV

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Participants With at Least One TEAE Per Treatment Group.

  Number and percentage of participants who experience at least one treatment-emergent adverse event (TEAE) per treatment group.

  Week 24

Secondary Outcomes (7)

• Percentage of Participants Achieving Clinical Response

  Week 16

• Percentage of Participants With Clinical Remission (BVAS = 0)

  Week 16

• IFX-1 Concentration Pre-dose

  Week 16

• IFX 1 Concentration at Predose (0 Hours), After the End of the Infusion (+10minutes), and at 2, 6, 24, and 48 Hours After the Start of the Infusion for Participants in the PK Substudy

  Weeks 1, 4 and 16

• C5a Plasma Concentration

  Week 16

Study Arms (3)

IFX-1 low dose

EXPERIMENTAL

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

Drug: IFX-1 low dose

IFX-1 high dose

EXPERIMENTAL

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

Drug: IFX-1 high dose

Placebo

PLACEBO COMPARATOR

Will receive placebo

Drug: Placebo

Interventions

IFX-1 low dose DRUG

Single IV infusions of IFX-1

Also known as: CaCP29

IFX-1 low dose

IFX-1 high dose DRUG

Single IV infusions of IFX-1

Also known as: CaCP29

IFX-1 high dose

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• InflaRx GmbH: lead
• Iqvia Pty Ltd: collaborator

Study Sites (38)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Loma Linda University Clinical Trial Center

Loma Linda, California, 92354, United States

Location

Science Connections, LLC

Doral, Florida, 33166, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160, United States

Location

LSU Health Sciences Center Shreveport

Shreveport, Louisiana, 71103, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University Of MI Medcl Ctr-RHU

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48084, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Northwell Health, LLC PRIME

New Hyde Park, New York, 11042, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

University of Rochester Medical Center - Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

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

Chapel Hill, North Carolina, 27599-7155, United States

Location

Trinity Medical Group

Minot, North Dakota, 58701, United States

Location

Ohio State University Clinical Trials Management Office

Columbus, Ohio, 43203, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

BRCR Medical Center, Inc.

Camp Hill, Pennsylvania, 17011, United States

Location

Altoona Center for Clinical Research, P.C.

Duncansville, Pennsylvania, 16635, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Low Country Rheumatology, PA

North Charleston, South Carolina, 29406, United States

Location

Adriana Pop Moody Clinic PA

Corpus Christi, Texas, 78404, United States

Location

Texas Health Resources

Dallas, Texas, 75287, United States

Location

Texas Research Institute

Fort Worth, Texas, 76104, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States

Location

UVA University Physicians Charlottesville

Charlottesville, Virginia, 22903, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

St. Josephs Healthcare

Hamilton, Ontaria, L8N 4A6, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

CHUM Centre de Recherche

Québec, Quebec, H2X 0A9, Canada

Location

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G8Z1Y2, Canada

Location

Related Publications (1)

• Serling-Boyd N, Wallace ZS. Management of primary vasculitides with biologic and novel small molecule medications. Curr Opin Rheumatol. 2021 Jan;33(1):8-14. doi: 10.1097/BOR.0000000000000756.

  PMID: 33164993 DERIVED

MeSH Terms

Conditions

Granulomatosis with Polyangiitis; Microscopic Polyangiitis

Interventions

vilobelimab

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Prof. Niels C. Riedemann
• Organization: InflaRx GmbH

niels.Riedemann@inflarx.de

+49 3641-508-180

Study Officials

• Korinna Pilz, MD, MS

  InflaRx GmbH

  STUDY DIRECTOR

• Peter A. Merkel, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 19, 2018
• Study Start: October 15, 2018
• Primary Completion: September 10, 2020
• Study Completion: May 3, 2021
• Last Updated: May 26, 2022
• Results First Posted: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (33); CA (5)