Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
Condition: Granulomatosis With Polyangiitis (GPA); Microscopic Polyangiitis (MPA)
MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Systemic Vasculitis
Intervention: IFX-1; Placebo-IFX-1; Glucocorticoid (GC); Placebo-Glucocorticoid (Placebo-GC)
Intervention description: intravenously administered; intravenously administered; orally administered; orally administered
Intervention MeSH terms: Prednisone; Glucocorticoids; Vilobelimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: granulomatosis; polyangiitis; corticosteroid; replacement; glucocorticoid

Summary:

      The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for
      glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis
      (MPA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

          -  Have ≥ 1 "major" item, or ≥ 3 other items, or ≥ 2 renal items on the Birmingham
             Vasculitis Activity Score Version 3 (BVASv3).

          -  Newly diagnosed or relapsed GPA or MPA that requires treatment with Cyclophosphamide
             (CYC) or Rituximab (RTX) plus GCs.

          -  Glomerular filtration rate ≥ 20 mL/min/1.73 m².

        Exclusion Criteria:

          -  Any other multi-system autoimmune disease.

          -  Require mechanical ventilation at screening.

          -  Known hypersensitivity to any investigational medicinal product and/or any excipient.

          -  Rare hereditary problems of galactose intolerance, total lactase deficiency or
             glucose-galactose malabsorption.

          -  Have required management of infections, as follows (a) Chronic infection requiring
             anti-infective therapy within 3 months before screening. (b) Use of intravenous
             antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days of
             screening

          -  Current and/or history (within the previous 5 years) of drug and/or alcohol abuse
             and/or dependence.

          -  Evidence of Hep B, C and/ or HIV infection. Only subjects with documented negative
             historical results (within 4 weeks before screening) for Hep B,C Virus and HIV or a
             negative test by Screening can be included into the study.

          -  Abnormal laboratory findings at screening

          -  Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder

          -  Received CYC or RTX within 12 weeks before screening or within 12 weeks before CYC or
             RTX is started for remission induction within 2 weeks before screening.

          -  Received > 3 g cumulative intravenous GCs within 4 weeks before screening.

          -  Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6
             weeks continuously prior to screening.

          -  Received an oral daily dose of a GC of > 80 mg prednisone equivalent within 2 weeks
             before screening.

          -  Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept,
             alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin
             (Ig) or plasma exchange, antithymocyte globulin, or required renal dialysis within 12
             weeks before screening.

          -  Received a live vaccination within 4 weeks before screening

          -  Either active or latent tuberculosis treatment is ongoing.

          -  Pregnant or lactating.

          -  Abnormal electrocardiogram.

          -  Female subjects of childbearing potential unwilling or unable to use a highly
             effective method of contraception

          -  Participation in an investigational clinical study during the 12 weeks before
             screening.

          -  Male subjects with female partners of childbearing potential unwilling to use
             contraception