Completed

This study has been completed.

Iptacopan in Patients With ANCA Associated Vasculitis

NCT06388941Sponsor: Novartis PharmaceuticalsMatthew WeirMatthew Weir

About This Study

This randomized, controlled trial evaluates the efficacy and safety of iptacopan, an oral factor B inhibitor, for inducing and maintaining remission in patients with newly diagnosed or relapsed active GPA or MPA. Participants receive iptacopan or placebo in combination with a rituximab induction regimen. The study assesses primary outcomes related to clinical remission and secondary endpoints including disease relapse rates, GC-related toxicity, and changes in eGFR and UPCR. The target population includes patients with active ANCA-associated vasculitis requiring induction therapy.

Who Can Participate?

✓ 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.