Comparing Avacopan Plus Short-Term Reduced-Dose Glucocorticoids and Rituximab Versus Reduced-Dose Glucocorticoids and Rituximab for Treating New ANCA-Associated Vasculitis

What this Trial Is About

Researchers are investigating the treatment of newly diagnosed ANCA-associated vasculitis, a serious condition affecting small- to medium-sized blood vessels. This phase 4 trial compares the effectiveness and safety of avacopan combined with short-term reduced-dose glucocorticoids and rituximab versus a longer course of reduced-dose glucocorticoids with rituximab. The study aims to understand if avacopan can achieve similar remission rates and reduce relapse compared to current therapies, while also assessing long-term safety. Participants will be randomly assigned to one of two treatment groups. One group receives avacopan daily along with a 4-week reduced-dose prednisolone course and rituximab infusions. The other group receives reduced-dose prednisolone tapered over 20 weeks plus rituximab infusions at scheduled times. Both groups have options for short-term rescue prednisolone if needed. Maintenance therapy continues with either avacopan or rituximab at regular intervals up to 24 months. Throughout the 104-week study, participants will be evaluated at multiple timepoints for disease activity, remission status, relapse, organ damage, and any adverse events. Assessments include standardized vasculitis activity scores and damage indices, quality of life questionnaires, and monitoring for side effects such as infections and new medical conditions. The main outcome measured is the proportion of patients achieving remission at 26 weeks, with ongoing follow-up to observe relapse rates and long-term safety.

Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis