An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases

Korábbi kezelés

• Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease
• Receipt of B cell depleting therapies or anti-BAFF and/or APRIL therapies within protocol specified timeframes
  • Part B:

Más betegség

• Recent serious or ongoing infection; risk or history of serious infection
• History of poor compliance with IP and/or procedures in Part A, as deemed by the investigator or Sponsor
• History of any AEs or clinical conditions during Part A or emerging thereafter that may pose a safety concern for participation in Part B as deemed by investigator or Sponsor.
  • Other protocol defined Inclusion/Exclusion criteria will apply

Laborértékek

• eGFR <30 milliliter per minute per square meter (mL/min/1.73m\^2) or rapidly progressive glomerulonephritis

Egyéb

• Part A:

• Part A:
• Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN)
• On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1
• Indication-specific criteria:
  • IgAN
  • Biopsy-confirmed diagnosis less than or equal to (≤)10 years prior to the start of screening AND Screening UPCR greater than or equal to (≥)0.5 g/g.
  • No background immunosuppression therapies.
  • pMN
  • A historical biopsy-confirmed diagnosis with positive anti-PLA2R1 antibodies or anti-THSD7A antibodies at screening AND Screening UPCR ≥1 g/g
  • Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at least 12 weeks.
  • No background immunosuppression therapies except for optional calcineurin inhibitors.
  • LN
  • A Biopsy-confirmed diagnosis of active, proliferative Class III, IV, (with or without Class V) LN ≤6 months prior to the start of screening AND Screening UPCR ≥1 g/g,
  • Anti-dsDNA at screening. Anti-dsDNA testing is required but the result need not be positive.
  • On stable background immunosuppression ≥ 8 weeks prior to Day 1
  • AAV
  • Past diagnosis of renal AAV, defined as either of the following:
  • History of renal biopsy consistent with renal AAV.
  • History of clinically diagnosed renal AAV.
  • Myeloperoxidase (MPO)-ANCA or proteinase 3 (PR3)-ANCA positive by enzyme-linked immunosorbent assay at screening.
  • At least 4 weeks since initiation of AAV induction therapy, if applicable.
  • Part B:
• Participants meet at least 1 of the following criteria:
  • Completed investigational product (IP) treatment and 24 weeks of follow-up in Part A, or
  • Had IP interruption(s) in Part A, but did not permanently discontinue IP, and completed study visits up to the last scheduled visit of the follow-up period of Part A.