Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

Related Clinical Trial
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis Hydroxychloroquine in ANCA Vasculitis Evaluation Vasculitis Illness Perception (VIP) Study Reproductive Health in Men and Women With Vasculitis Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis Impact of Vasculitis on Employment and Income Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases VCRC Tissue Repository Yellow Fever Vaccine in Patients With Rheumatic Diseases Journey of Patients With Vasculitis From First Symptom to Diagnosis One-Time DNA Study for Vasculitis Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. Clinical Transcriptomics in Systemic Vasculitis (CUTIS) The ANCA Vasculitis Questionnaire (AAV-PRO©) Vasculitis Pregnancy Registry VCRC Patient Contact Registry Patient-Reported Data Validation Study Educational Needs of Patients With Systemic Vasculitis Diagnostic Effectiveness of Virtual Bronchoscopy Alemtuzumab for ANCA Associated Refractory Vasculitis Interventional Cryotherapy for the Eradication of Benign Airway Disease (“ICE the BAD”) PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides Plasma Exchange for Renal Vasculitis PRO Development for ANCA Associated Vasculitis BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides Rituximab Vasculitis Maintenance Study Anti-Cytokine Therapy for Vasculitis Rituximab and Belimumab Combination Therapy in PR3 COMBIVAS American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis Low-dose Glucocorticoid Vasculitis Induction Study Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. The Assessment of Prednisone In Remission Trial (TAPIR) – Patient Centric Approach Steroids and Methotrexate to Treat Systemic Vasculitis Efficacy Study of Two Treatments in the Remission of Vasculitis Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener’s) Rituximab for the Treatment of Wegener’s Granulomatosis and Microscopic Polyangiitis Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener’s) and Microscopic Polyangiitis Mycophenolate Mofetil for Treatment of Relapses of Wegener’s Disease or Microscopic Polyangiitis (MPA) Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) Daclizumab to Treat Wegener’s Granulomatosis An Open Label Pilot Study Examining the Use of Rituximab in Patients With Wegener’s Granulomatosis Who Have Experienced Disease Relapse on Standard Therapies Etanercept to Treat Wegener’s Granulomatosis Treatment of Wegener’s Granulomatosis With Cyclophosphamide Mycophenolate Mofetil to Treat Wegener’s Granulomatosis and Related Vascular Inflammatory Conditions Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener’s Granulomatosis Comparison of Treatments to Maintain Disease Remission in Patients With Wegener’s Granulomatosis and Related Vasculitis Syndromes Neutrophils as Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener’s Granulomatosis) Natural History of Granulomatosis With Polyangiitis: Clinical and Genetic Biomarkers of Airway Disease NoAAC PR-03 Study Analysis of Bronchial Tissue and Fluid in Patients With Wegener’s Granulomatosis TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Study of One Protein Implicated in Wegener Disease Abatacept in Treating Adults With Mild Relapsing Wegener’s Granulomatosis Phase II Study on Gusperimus in Patients With Refractory Wegener’s Granulomatosis Etanercept for Wegener’s Granulomatosis Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener’s Granulomatosis

Brief Title

Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

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)

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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Proportion of subjects achieving clinical response (reduction in BVAS of ≥50% and no worsening in any body system)

Condition

Granulomatosis With Polyangiitis (GPA)

Intervention

IFX-1

Study Arms / Comparison Groups

 Group A
Description:  Will receive IFX-1 low dose regimen diluted in sodium chloride solution

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

36

Start Date

October 15, 2018

Completion Date

December 31, 2021

Primary Completion Date

September 30, 2021

Eligibility Criteria

        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).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Korinna Pilz, MD, MS, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03712345

Organization ID

IFX-1-P2.6


Responsible Party

Sponsor

Study Sponsor

InflaRx GmbH

Collaborators

 Iqvia Pty Ltd

Study Sponsor

Korinna Pilz, MD, MS, Study Director, InflaRx GmbH


Verification Date

May 2021