Iptacopan in Patients With ANCA Associated Vasculitis

Launched by NOVARTIS PHARMACEUTICALS · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called iptacopan to see how well it works compared to standard treatments for patients with a type of autoimmune disease known as ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). The trial aims to find out if iptacopan can help patients achieve and maintain remission, which means reducing or stopping the symptoms of their disease. Researchers will also look at how iptacopan affects kidney function, disease relapses, side effects from corticosteroids (a common treatment), and the overall quality of life for participants.

To be eligible for this trial, patients should have been newly diagnosed or have had a relapse of GPA or MPA and need treatment with rituximab (another medication). They must also have specific markers in their blood indicating the presence of the disease. However, those with other serious health issues or severe kidney problems may not qualify. Participants can expect regular check-ups and will be closely monitored throughout the study to ensure their safety and to see how well the treatment works. This trial is currently recruiting patients of all genders aged 65 to 74.

Gender

ALL

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.