Iptacopan in Patients With ANCA Associated Vasculitis

Novartis

Status and phase: Active, not recruiting; Phase 2

Conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis

Treatments: Drug: Rituximab; Drug: Iptacopan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06388941

2023-510525-15-00 (Other Identifier)

CLNP023R12201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed or relapsed GPA and MPA (according to the 2022 ACR/EULAR classification criteria for GPA and MPA) requiring treatment with RTX and GC as per investigator's judgement.
• BVAS assessment with ≥1 major item, or ≥3 minor items, or ≥2 renal items at Screening.
• Positive antibody test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO) antibodies at Screening or with history of documented evidence of a positive antibody test.

Exclusion criteria

• Other systemic disease which constitutes the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), moderate to severe systemic lupus erythematosus, IgA vasculitis (Purpura Schönlein-Henoch), rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane (GBM) disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, autoimmune lymphoproliferative syndrome or mixed connective tissue disease.
• Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening.
• Severe kidney disease defined as estimated glomerular filtration rate (eGFR) <15 mL/minute/1.73m2, or kidney failure defined as receiving renal replacement therapy such as hemo(dia)filtration, hemo-/peritoneal dialysis, or having received a kidney transplant.
• Received plasma exchange/-pheresis within 12 weeks prior to Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Iptacopan

Experimental group

Description:

LNP023 administered orally

Treatment:

Drug: Iptacopan

Drug: Rituximab

Control

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo

Drug: Rituximab