Phase 2 Study to Assess Safety and Effectiveness of Tarperprumig in Adults With Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What this Trial Is About

Researchers are evaluating the safety and tolerability of tarperprumig in adults diagnosed with or experiencing a relapse of anti-neutrophil cytoplasmic antibody ANCA-associated vasculitis, specifically targeting granulomatosis with polyangiitis GPA and microscopic polyangiitis MPA subtypes. This phase 2 study aims to explore tarperprumigs effects compared to placebo in participants considered for treatment with rituximab or cyclophosphamide. Participants will be randomized to receive one of two dose regimens of tarperprumig or a placebo in a double-blind, parallel-group design. The treatment period lasts up to 70 weeks, during which participants receive their assigned study drug. The study uses a quadruple masking approach to ensure unbiased results and compares safety, tolerability, and efficacy outcomes among groups. Throughout the study, participants will undergo regular assessments including monitoring for treatment-emergent adverse events, evaluations of disease remission status, and measurements of disease activity using the Birmingham Vasculitis Activity Score BVAS. Additional tests include kidney function assessments and proteinuria measurements at baseline and at scheduled weeks. Safety and disease progression will be closely followed up to week 70, with comprehensive data collection on vasculitis damage and relapse occurrences.

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