Iptacopan in Patients With ANCA Associated Vasculitis

Summary

The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL.

Timeline

Start

2024-08-05

Primary completion

2026-12-30

Completion

2026-12-30

Publications

• Brilland B, Riou J, Quemeneur T, Vandenbussche C, Merillon N, Boizard-Moracchini A, Roy M, Despre M, Piccoli GB, Djema A, Henry N, Preisser L, Blanchet O, Gnemmi V, Copin MC, Langlais D, Jeannin P, Blanco P, Delneste Y, Augusto JF; Maine-Anjou Registry Research Group. Identification of Renal Transcripts Associated with Kidney Function and Prognosis in ANCA-Associated Vasculitis. J Am Soc Nephrol. 2026 Jan 1;37(1):131-149. doi: 10.1681/ASN.0000000779. Epub 2025 Jul 9.

Drugs

Indications