Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. (IXchange)

This is an interventional treatment trial for Granulomatosis With Polyangiitis (GPA) focused on measuring granulomatosis, polyangiitis, corticosteroid, replacement, glucocorticoid Read More

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