Trial Profile

A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Partial Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis

Status: Completed

Phase of Trial: Phase I/II

Latest Information Update: 22 Aug 2025

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At a glance

Drugs BDB 001 Beijing Defengrei Biotechnology (Primary) ; Cyclophosphamide; Prednisone
Indications Granulomatosis with polyangiitis; Vasculitis
Focus Therapeutic Use
Sponsors Staidson Beijing BioPharmaceuticals

07 Aug 2025 According to an InflaRx media release, In July 2025, Staidson BioPharmaceuticals announced, based on the data from this trial, company plans to advance BDB-001 into Phase 3 trials in AAV.
07 Aug 2025 Primary endpoint has been met (The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)) , according to an InflaRx media release
07 Aug 2025 Results published in an InflaRx media release

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