NCT06388941

Iptacopan in Patients With ANCA Associated Vasculitis

A Randomized, Controlled Study to Evaluate LNP023 (Iptacopan) in Patients With Active ANCA-associated Vasculitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, controlled study to evaluate the efficacy and safety of iptacopan in combination with RTX induction therapy for the treatment of newly diagnosed or relapsed patients with active GPA or MPA.

Conditions

• Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis

Interventions

Type	Name	Description
DRUG	Iptacopan	LNP023 administered orally
DRUG	Placebo	Matching placebo administered orally
DRUG	Rituximab	Standard of care

Timeline

• Start date: 2024-08-05
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-04-29
• Last updated: 2026-03-30

Locations

47 sites across 15 countries: United States, Argentina, Australia, Austria, Belgium, Canada, China, Czechia, Denmark, France, Germany, Hungary, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study