NCT05376319

PR3-AAV Resilient Remission or PRRR

A Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effect of Obinutuzumab Versus Rituximab in PR3-Patients With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab for the treatment of proteinase 3 Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (PR3-AAV).

Conditions

• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis
• ANCA Associated Vasculitis

Interventions

Type	Name	Description
DRUG	Obinutuzumab	1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
DRUG	Rituximab	1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15

Timeline

• Start date: 2023-06-30
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2022-05-17
• Last updated: 2024-07-31
• Results posted: 2024-07-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study