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A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy.
Mathur, Mohit; Barratt, Jonathan; Chacko, Bobby; Chan, Tak Mao; Kooienga, Laura; Oh, Kook-Hwan; Sahay, Manisha; Suzuki, Yusuke; Wong, Muh Geot; Yarbrough, Jill; Xia, Jing; Pereira, Brian J G.
Affiliation
  • Mathur M; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Barratt J; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Chacko B; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Chan TM; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Kooienga L; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Oh KH; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Sahay M; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Suzuki Y; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Wong MG; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Yarbrough J; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Xia J; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
  • Pereira BJG; From Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Aus
N Engl J Med ; 390(1): 20-31, 2024 Jan 04.
Article in En | MEDLINE | ID: mdl-37916620
BACKGROUND: A proliferation-inducing ligand (APRIL) is implicated in the pathogenesis of IgA nephropathy. Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to and neutralizes APRIL. METHODS: In this phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial, we randomly assigned adults with biopsy-confirmed IgA nephropathy who were at high risk for disease progression, despite having received standard-care treatment, in a 1:1:1:1 ratio to receive intravenous sibeprenlimab at a dose of 2, 4, or 8 mg per kilogram of body weight or placebo once monthly for 12 months. The primary end point was the change from baseline in the log-transformed 24-hour urinary protein-to-creatinine ratio at month 12. Secondary end points included the change from baseline in the estimated glomerular filtration rate (eGFR) at month 12. Safety was also assessed. RESULTS: Among 155 patients who underwent randomization, 38 received sibeprenlimab at a dose of 2 mg per kilogram, 41 received sibeprenlimab at a dose of 4 mg per kilogram, 38 received sibeprenlimab at a dose of 8 mg per kilogram, and 38 received placebo. At 12 months, the geometric mean ratio reduction (±SE) from baseline in the 24-hour urinary protein-to-creatinine ratio was 47.2±8.2%, 58.8±6.1%, 62.0±5.7%, and 20.0±12.6% in the sibeprenlimab 2-mg, 4-mg, and 8-mg groups and the placebo group, respectively. At 12 months, the least-squares mean (±SE) change from baseline in eGFR was -2.7±1.8, 0.2±1.7, -1.5±1.8, and -7.4±1.8 ml per minute per 1.73 m2 in the sibeprenlimab 2-mg, 4-mg, and 8-mg groups and the placebo group, respectively. The incidence of adverse events that occurred after the start of administration of sibeprenlimab or placebo was 78.6% in the pooled sibeprenlimab groups and 71.1% in the placebo group. CONCLUSIONS: In patients with IgA nephropathy, 12 months of treatment with sibeprenlimab resulted in a significantly greater decrease in proteinuria than placebo. (Funded by Visterra; ENVISION ClinicalTrials.gov number, NCT04287985; EudraCT number, 2019-002531-29.).
Subject(s)

Full text: 1 Database: MEDLINE Main subject: Tumor Necrosis Factor Ligand Superfamily Member 13 / Antibodies, Monoclonal, Humanized / Glomerulonephritis, IGA Limits: Adult / Humans Language: En Journal: N Engl J Med Year: 2024 Type: Article

Full text: 1 Database: MEDLINE Main subject: Tumor Necrosis Factor Ligand Superfamily Member 13 / Antibodies, Monoclonal, Humanized / Glomerulonephritis, IGA Limits: Adult / Humans Language: En Journal: N Engl J Med Year: 2024 Type: Article