Iptacopan in Patients With ANCA Associated Vasculitis

Conditions

• Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Iptacopan — DRUG
  LNP023 administered orally
• Placebo — DRUG
  Matching placebo administered orally
• Rituximab — DRUG
  Standard of care

Study Details

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.

Key Dates

Start date

Aug 5, 2024

Status verified

May 2026

Primary completion

Dec 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

84 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Iptacopan
  LNP023 administered orally
• Placebo Comparator: Control
  Matching placebo

Primary Outcome Measure

Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48. [ Time Frame: At Week 48 ]

Locations (3)

Find similar trials in Mesa, AZ