Asahi

Researchers are evaluating treatments for newly diagnosed ANCA-associated vasculitis, a serious disease involving inflammation of small to medium blood vessels. This phase 4 trial compares whether avacopan combined with short-term reduced-dose glucocorticoids and rituximab works as well as a longer 20-week reduced-dose glucocorticoid and rituximab treatment for achieving remission. The study also examines if avacopan lowers relapse rates compared to rituximab maintenance therapy and assesses the long-term safety of avacopan. Participants will be randomly assigned to one of two treatment groups. One group receives avacopan with short-term (up to 4 weeks) reduced-dose prednisolone and rituximab given at the start. The other group receives reduced-dose prednisolone for up to 20 weeks combined with rituximab administered at weeks 0, 26, 52, and 78. The study is open-label and will follow patients for up to 104 weeks to compare remission, relapse, and safety outcomes. Patients will be evaluated at multiple time points from baseline through week 104. Assessments include disease status (remission or relapse), disease activity scores, damage indexes, and adverse events. The main outcome is the proportion of patients achieving remission at 26 weeks. Researchers will monitor long-term safety and relapse rates over two years to better understand the benefits and risks of these treatment approaches.