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

Launched by INFLARX GMBH · Mar 27, 2019

Keywords

ClinConnect Summary

Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a group of potentially life-threatening autoimmune diseases. Preclinical data demonstrate that primed neutrophils are activated by anti-neutrophil cytoplasmic antibody (ANCA) and generate C5a that engages C5a receptors on neutrophils. Patients with ANCA-related disease have elevated plasma and urine levels of C5a in active disease but not in remission. IFX-1 is as a monoclonal antibody specifically binding to the soluble human complement split product C5a, which results in nearly complete blockade of C5a induced biological ...

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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