Last updated 30 days ago

Iptacopan in Patients With ANCA Associated Vasculitis

78 patients around the world
Available in Argentina, United States
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.
Novartis Pharmaceuticals
3Research sites
78Patients around the world

This study is for people with

Vasculitis
ANCA-associated vasculitis (AAV)

Requirements for the patient

To 100 Years
All Gender

Medical requirements

Newly diagnosed or relapsed 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, rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane 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.

Sites

Fundación Sanatorio Güemes - CABA, Buenos Aires
Fundación Sanatorio Güemes - CABA, Buenos Aires
Recruiting
Fco Acuña de Figueroa 1228
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH
Hospital Italiano de La Plata
Recruiting
Av. 51 entre 29 y 30 Nro 1725, La Plata, Buenos Aires
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