Study Description
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. 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.
Interventions
Iptacopan
Placebo
Rituximab
Eligibility Criteria
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.
Novartis Investigative Site
Recruiting
Beijing,100034,China
Worldwide Contacts
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