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.
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.
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.
Parallel
Placebo
DrugParticipants will receive placebo.
Tarperprumig
DrugParticipants will receive tarperprumig.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of Participants Achieving Disease Remission at Week 26
Number of Participants Achieving Sustained Remission at Week 52
Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0
Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26
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