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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03712345
Other study ID # IFX-1-P2.6
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 15, 2018
Est. completion date May 3, 2021

Study information

Verified date May 2022
Source InflaRx GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date May 3, 2021
Est. primary completion date September 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IFX-1 low dose
Single IV infusions of IFX-1
IFX-1 high dose
Single IV infusions of IFX-1
Placebo
Placebo

Locations

Country Name City State
Canada University of Alberta Hospital Edmonton Alberta
Canada St. Josephs Healthcare Hamilton Ontaria
Canada CHUM Centre de Recherche Québec Quebec
Canada Mount Sinai Hospital Toronto Ontario
Canada Centre de Recherche Musculo-Squelettique Trois-Rivières Quebec
United States University of New Mexico Albuquerque New Mexico
United States University Of MI Medcl Ctr-RHU Ann Arbor Michigan
United States Johns Hopkins Bayview Medical Center Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States BRCR Medical Center, Inc. Camp Hill Pennsylvania
United States UNC Kidney Center, UNC-CH Division of Nephrology and Hypertension Chapel Hill North Carolina
United States UVA University Physicians Charlottesville Charlottesville Virginia
United States Rush University Medical Center Chicago Illinois
United States Ohio State University Clinical Trials Management Office Columbus Ohio
United States Adriana Pop Moody Clinic PA Corpus Christi Texas
United States Texas Health Resources Dallas Texas
United States Henry Ford Hospital Detroit Michigan
United States Science Connections, LLC Doral Florida
United States Altoona Center for Clinical Research, P.C. Duncansville Pennsylvania
United States Texas Research Institute Fort Worth Texas
United States Pioneer Research Solutions, Inc. Houston Texas
United States University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas
United States Loma Linda University Clinical Trial Center Loma Linda California
United States University of Miami Miami Florida
United States University of Minnesota Minneapolis Minnesota
United States Trinity Medical Group Minot North Dakota
United States West Virginia University Morgantown West Virginia
United States Northwell Health, LLC PRIME New Hyde Park New York
United States Hospital for Special Surgery New York New York
United States Low Country Rheumatology, PA North Charleston South Carolina
United States University of Pennsylvania Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Medical Center - Strong Memorial Hospital Rochester New York
United States Washington University Saint Louis Missouri
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States LSU Health Sciences Center Shreveport Shreveport Louisiana

Sponsors (2)

Lead Sponsor Collaborator
InflaRx GmbH Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Participants Achieving Clinical Response Efficacy Endpoint based on clinical response evaluated through BVAS. Clinical response is defined as a reduction in BVAS of =50% and no worsening in any body system and no administration of rescue medication prior to the response assessment. Week 16
Secondary Percentage of Participants With Clinical Remission (BVAS = 0) Efficacy Endpoint that evaluates participants with complete remission Week 16
Secondary IFX-1 Concentration Pre-dose Assess the pharmacokinetic of the investigational medicinal product. Week 16
Secondary 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 Analyze the IMP plasma concentration using a PK model: 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
Secondary C5a Plasma Concentration Pharmacodynamic parameter concentration Week 16
Secondary IFX-1 Blocking Activity 2.5 nM Pharmacodynamic Parameter of IFX-1 blocking activity 2.5 nM Week 16
Secondary IFX-1 Blocking Activity 10 nM Pharmacodynamic Parameter of IFX-1 blocking activity 10 nM Week 16
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Completed NCT03895801 - Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. Phase 2