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Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

RecruitingPhase 2Ages 18 Years - 80 YearsAllAlexion Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Newly diagnosed or relapsing ANCA-associated vasculitis, GPA and MPA subtypes consistent with the 2022 ACR/EULAR classification criteria for GPA and MPA for whom treatment with rituximab or cyclophosphamide is considered. * Positive test for antibodies to either PR3-ANCA or MPO-ANCA at Screening or in the past by a quantitative assay (for example, ELISA, bead assay). * At least one major item, or at least 3 minor items, or at least 2 renal items in the BVAS. Exclusion Criteria: * Other systemic diseases that, in the judgment of the Investigator, constitute the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus, IgA nephropathy and/or IgA associated vasculitis with or without Henoch-Schonlein purpura, rheumatoid vasculitis, Sjogren's syndrome, anti-GBM disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, or mixed connective tissue disease. * Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening. * Any diseases or conditions that, in the judgment of the Investigator, present a substantial clinical risk to participate in this study. * For patients with a previous diagnosis of CKD, patients known to have a stable eGFR for greater than 3 months prior to Screening and a decline less than 25% of previous eGFR at Screening will be excluded.
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What it tests

  • Placebo
  • Tarperprumig
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Where

78 sites
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
La Plata, Argentina
Research Site
Rosario, Argentina
Research Site
San Juan Bautista, Argentina
Research Site
Santa Fe, Argentina
Research Site
Clayton, Australia
Research Site
Heidelberg, Australia

โ€ฆand 70 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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