A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy

Korábbi kezelés

• Receipt of systemic immunosuppressive agents or procedures (including corticosteroids, oral immunosuppressive agents, protocol-specified herbal medicines, or tonsillectomy) within the protocol-defined washout period.
• Previous or current treatment (including in a prior clinical trial) with anti-APRIL biologics, anti-CD38 therapy, or anti-CD20 therapy.
  • Anti-APRIL biologics
  • Anti-CD38 therapy
  • Anti-CD20 therapy
• Receipt of an investigational compound or complement inhibitor within 30 days or 5 half-lives (whichever is longer) prior to screening.
• Presence of or history of nephrotic syndrome, defined as 24-hour urine protein \>3.5 g/day with concurrent hypoalbuminemia.

Más betegség

• Any chronic infectious disease (e.g., chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary tuberculosis, or systemic tuberculosis).

Laborértékek

• Serum IgG level \<6 g/L (\<600 mg/dL).
  • Other protocol-defined inclusion and exclusion criteria may apply.

Egyéb

• Secondary forms of IgAN, or ongoing IgA vasculitis (Henoch-Schönlein purpura) with systemic involvement requiring immunosuppressive treatment.
• Known or clinically suspected rapidly progressive glomerulonephritis (RPGN).
• Body weight \<40 kg or morbid obesity.

• Adult participants with biopsy-confirmed primary IgAN.
• UPCR ≥0.75 g/g or 24-hour protein excretion ≥1 g/day, as measured from an adequately collected 24-hour urine sample.
• eGFR ≥30 mL/min/1.73 m².
• Stable and maximally tolerated doses of ACEi and/or ARB according to standard of care and applicable guidelines for at least 12 weeks prior to the initial screening visit.