drugset / Trial / NCT05248646
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
Phase 3
Active not recruiting
530 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
RandomizedParallel-groupDouble-blindTreatment
Summary
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
Timeline
- Start
- 2022-03-15
- Primary completion
- 2026-05-13
- Completion
- 2027-01-19
Publications
- Perkovic V, Barratt J, Lafayette R, Liew A, Suzuki Y, Carroll K, Cheung CK, Tesar V, Trimarchi H, Wong MG, Zhang H, Xia J, Fajardo C, Shah L, Hafkin J, Rizk DV. Evaluating Sibeprenlimab in IgA Nephropathy - Rationale and Baseline Data from the VISIONARY Trial. Kidney Int Rep. 2025 Oct 1;10(12):4207-4218. doi: 10.1016/j.ekir.2025.09.031. eCollection 2025 Dec.
- Perkovic V, Trimarchi H, Tesar V, Lafayette R, Wong MG, Barratt J, Suzuki Y, Liew A, Zhang H, Carroll K, Jha V, Quevedo A, Han SH, Praga M, Chacko B, Sahay M, Cheung CK, Kooienga L, Walsh M, Xia J, Fajardo C, Shah L, Hafkin J, Rizk DV; VISIONARY Trial Investigators Group. Sibeprenlimab in IgA Nephropathy - Interim Analysis of a Phase 3 Trial. N Engl J Med. 2026 Feb 12;394(7):635-646. doi: 10.1056/NEJMoa2512133. Epub 2025 Nov 8.
- Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sibeprenlimab | Monoclonal antibody | 400 mg | Subcutaneous |