Last updated 43 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
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Hospital Italiano de La Plata
Recruiting
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
ANCA-associated vasculitis (AAV)
Requirements
To 100 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06388941
