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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03712345
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : May 12, 2021
Iqvia Pty Ltd
Information provided by (Responsible Party):
InflaRx GmbH

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.

Condition or disease Intervention/treatment Phase
Granulomatosis With Polyangiitis (GPA) Microscopic Polyangiitis (MPA) Drug: IFX-1 Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Group A
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
Drug: IFX-1
Single IV infusions of IFX-1
Other Name: CaCP29

Experimental: Group B
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
Drug: IFX-1
Single IV infusions of IFX-1
Other Name: CaCP29

Placebo Comparator: Group C
Will receive placebo
Drug: Placebo

Primary Outcome Measures :
  1. Number and percentage of subjects who experience at least one treatment-emergent adverse event (TEAE) per treatment group. [ Time Frame: Week 24 ]
    Safety parameters will be evaluated (number of total TEAEs)

Secondary Outcome Measures :
  1. Proportion of subjects achieving clinical response (reduction in BVAS of ≥50% and no worsening in any body system) [ Time Frame: Week 16 ]
    Efficacy Endpoint based on clinical response evaluated through BVAS.

  2. Proportion of subjects with clinical remission (BVAS = 0) [ Time Frame: Week 16 ]
    Efficacy Endpoint that evaluates subjects with complete remission

  3. IFX 1 concentration pre- and postdose at each IMP administration visit [ Time Frame: Week 0 to Week 16, Week 20 and Week 24 ]
    Assess the pharmacokinetic of the investigational medicinal product.

  4. 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 subjects in the PK substudy [ Time Frame: Weeks 1, 4 and 16 ]
    Analyze the IMP plasma concentration using a PK model.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT03712345

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Sponsors and Collaborators
InflaRx GmbH
Iqvia Pty Ltd
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Study Director: Korinna Pilz, MD, MS InflaRx GmbH
Principal Investigator: Peter A. Merkel, MD, MPH University of Pennsylvania
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Responsible Party: InflaRx GmbH Identifier: NCT03712345    
Other Study ID Numbers: IFX-1-P2.6
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by InflaRx GmbH:
Granulomatosis with Polyangiitis (GPA)
Microscopic Polyangiitis (MPA)
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents