Microscopic Polyangiitis (MPA) Clinical Trial
Official title:
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
Verified date | May 2022 |
Source | InflaRx GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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(MTX), mycophenolate mofetil (MMF), or mycophenolate sodium (MPS) at the time of Screening, these drugs must be withdrawn prior to receiving CYC or RTX. 5.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). |
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 |
Lead Sponsor | Collaborator |
---|---|
InflaRx GmbH | Iqvia Pty Ltd |
United States, Canada,
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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