Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
Condition: Granulomatosis With Polyangiitis (GPA); Microscopic Polyangiitis (MPA)
MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Systemic Vasculitis
Intervention: IFX-1 low dose; IFX-1 high dose; Placebo
Intervention description: Single IV infusions of IFX-1; Single IV infusions of IFX-1; Placebo
Intervention MeSH terms: Vilobelimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Granulomatosis with Polyangiitis (GPA); Microscopic Polyangiitis (MPA); IFX-1; ANCA; AAV

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.
    

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             Screening, these drugs must be withdrawn prior to receiving CYC or RTX.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).