Iptacopan in Patients With ANCA Associated Vasculitis

Inclusion Criteria:

• Newly diagnosed or relapsed GPA and MPA (according to the 2022 ACR/EULARclassification criteria for GPA and MPA) requiring treatment with RTX and GC as perinvestigator's judgement.

• BVAS assessment with ≥1 major item, or ≥3 minor items, or ≥2 renal items atScreening.

• Positive antibody test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO)antibodies at Screening or with history of documented evidence of a positiveantibody test.

Exclusion Criteria:

• Other systemic disease which constitutes the primary illness, including but notlimited to: eosinophilic granulomatosis with polyangiitis (EGPA), moderate to severesystemic lupus erythematosus, IgA vasculitis (Purpura Schönlein-Henoch), rheumatoidvasculitis, Sjögren's syndrome, anti-glomerular basement membrane (GBM) disease,cryoglobulinemic vasculitis, autoimmune hemolytic anemia, autoimmunelymphoproliferative 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) <15mL/minute/1.73m2, or kidney failure defined as receiving renal replacement therapysuch as hemo(dia)filtration, hemo-/peritoneal dialysis, or having received a kidneytransplant.

• Received plasma exchange/-pheresis within 12 weeks prior to Screening.