Phase III Study of BDB-001 Injection Combined With Cyclophosphamide, Azathioprine, or Rituximab for Treating ANCA-Associated Vasculitis

What this Trial Is About

Researchers are evaluating the effectiveness of BDB-001 injection combined with cyclophosphamide followed by azathioprine, or combined with rituximab, in inducing remission for patients with active ANCA-associated vasculitis AAV. This phase III clinical trial aims to determine how well these treatments work in comparison to standard therapy with prednisone, focusing on disease remission and safety. Participants will be randomly assigned to receive either BDB-001 injection plus cyclophosphamideazathioprine or rituximab with a prednisone placebo, or a prednisone treatment combined with cyclophosphamideazathioprine or rituximab and a placebo matching BDB-001. All treatments are administered intravenously. The study evaluates disease remission at 24 weeks and sustained remission, relapse rates, kidney function changes, glucocorticoid toxicity, and quality of life over 48 weeks. Throughout the trial, participants will have regular assessments including measurements of disease activity using the Birmingham Vasculitis Activity Score BVAS, kidney function tests, and quality of life questionnaires. Safety and treatment effects will be monitored closely. Total participation lasts up to 48 weeks, with the main outcome measured at 24 weeks to determine remission status.

BDB-001 Phase III Trial in ANCA-Associated Vasculitis