Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
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|ClinicalTrials.gov Identifier: NCT03712345|
Recruitment Status : Terminated (Due to COVID-19 pandemic outbreak and its impact on overall study activities. All efforts were made to ensure that participants that were enrolled and/or were still in the study will continue to receive treatment and follow-up until study completion.)
First Posted : October 19, 2018
Results First Posted : May 26, 2022
Last Update Posted : May 26, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Granulomatosis With Polyangiitis (GPA) Microscopic Polyangiitis (MPA)||Drug: IFX-1 low dose Drug: IFX-1 high dose Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Actual Study Start Date :||October 15, 2018|
|Actual Primary Completion Date :||September 10, 2020|
|Actual Study Completion Date :||May 3, 2021|
Experimental: IFX-1 low dose
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
Drug: IFX-1 low dose
Single IV infusions of IFX-1
Other Name: CaCP29
Experimental: IFX-1 high dose
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
Drug: IFX-1 high dose
Single IV infusions of IFX-1
Other Name: CaCP29
Placebo Comparator: Placebo
Will receive placebo
- Number and Percentage of Participants With at Least One TEAE Per Treatment Group. [ Time Frame: Week 24 ]Number and percentage of participants who experience at least one treatment-emergent adverse event (TEAE) per treatment group.
- Percentage of Participants Achieving Clinical Response [ Time Frame: Week 16 ]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.
- Percentage of Participants With Clinical Remission (BVAS = 0) [ Time Frame: Week 16 ]Efficacy Endpoint that evaluates participants with complete remission
- IFX-1 Concentration Pre-dose [ Time Frame: Week 16 ]Assess the pharmacokinetic of the investigational medicinal product.
- 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 [ Time Frame: Weeks 1, 4 and 16 ]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
- C5a Plasma Concentration [ Time Frame: Week 16 ]Pharmacodynamic parameter concentration
- IFX-1 Blocking Activity 2.5 nM [ Time Frame: Week 16 ]Pharmacodynamic Parameter of IFX-1 blocking activity 2.5 nM
- IFX-1 Blocking Activity 10 nM [ Time Frame: Week 16 ]Pharmacodynamic Parameter of IFX-1 blocking activity 10 nM
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712345
|Study Director:||Korinna Pilz, MD, MS||InflaRx GmbH|
|Principal Investigator:||Peter A. Merkel, MD, MPH||University of Pennsylvania|
Documents provided by InflaRx GmbH:
|Responsible Party:||InflaRx GmbH|
|Other Study ID Numbers:||
|First Posted:||October 19, 2018 Key Record Dates|
|Results First Posted:||May 26, 2022|
|Last Update Posted:||May 26, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Granulomatosis with Polyangiitis (GPA)
Microscopic Polyangiitis (MPA)
Granulomatosis with Polyangiitis
Lung Diseases, Interstitial
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Skin Diseases, Vascular
Immune System Diseases
Cerebral Small Vessel Diseases
Central Nervous System Diseases
Nervous System Diseases
Complement Inactivating Agents
Physiological Effects of Drugs