Iptacopan in Patients With ANCA Associated Vasculitis
- Conditions
- Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
- Interventions
- Registration Number
- NCT06388941
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iptacopan Rituximab LNP023 administered orally Control Placebo Matching placebo Control Rituximab Matching placebo Iptacopan Iptacopan LNP023 administered orally
- Primary Outcome Measures
Name Time Method Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48. At Week 48 To assess the effect of iptacopan in achieving sustained remission compared to standard of care (SOC)
- Secondary Outcome Measures
Name Time Method B cell counts At Week 48 To assess participant's immune status
Total IgG levels At Week 48 To assess participant's immune status
Complete remission at week 24 At week 24 Remission is defined as Birmingham Vasculitis Activity Score (BVAS) equal zero. BVAS captures various vasculitis organ manifestations as weighted score describing persistent and new symptoms with higher scores indicating more severe disease.
Time to reach BVAS=0 At Week 24 To assess time to remission through Week 24
Time to major relapse At Week 48 To assess the effect of iptacopan on disease relapse
Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks At Week 48 To assess the effect of iptacopan on renal function
Cumulative dose of glucocorticoid (GC) At Week 48 To assess the effect of iptacopan on GC sparing
Trial Locations
- Locations (4)
Arizona Arthritis and Rheumatology Research PLLC
🇺🇸Mesa, Arizona, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Northwell Health
🇺🇸New York, New York, United States
Novartis Investigative Site
🇹🇷Pendik Istanbul, Turkey