| sibeprenlimab (VIS649) / Otsuka |
2021-005526-17: Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy Ensayo abierto de fase II/III con sibeprenlimab en el tratamiento de la nefropatía por inmunoglobulina A |
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| Ongoing | 3 | 600 | Europe | Sibeprenlimab, VIS649, Solution for injection | Otsuka Pharmaceutical Development and Commercialization, Inc., Otsuka Pharmaceutical Development & Commercialization, Inc. | Immunoglobulin A Nephropathy Nefropatía por inmunoglobulina A, A kidney disease that occurs when antibody deposits build up in the kidneys Una enfermedad renal que ocurre cuando se acumulan depósitos de anticuerpos en los riñones, Diseases [C] - Immune System Diseases [C20] | | | | |
NCT05248646: Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN) |
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| Active, not recruiting | 3 | 530 | US | Sibeprenlimab 400 mg, VIS649, Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Immunoglobulin A Nephropathy | 12/26 | 12/26 | | |
NCT05248659: Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy |
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| Enrolling by invitation | 2/3 | 600 | US | Sibeprenlimab 400 mg s.c. Q4weeks, VIS649 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Immunoglobulin A Nephropathy | 12/28 | 12/28 | | |
2019-002531-29: A study to look at the effect and how safe drug VIS649 is in patients with kidney disease |
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| Not yet recruiting | 2 | 144 | Europe | VIS649, VIS649, Concentrate for solution for infusion | Visterra, Inc., Visterra, Inc. | Immunoglobulin A (IgA) Nephropathy, A kidney disease that occurs when antibody deposits build up in the kidneys, Diseases [C] - Immune System Diseases [C20] | | | | |
| Completed | 2 | 155 | Europe, Canada, Japan, US, RoW | Dose-Placebo, Low Dose-VIS649, Medium Dose-VIS649, High Dose-VIS649 | Visterra, Inc. | Immunoglobulin A Nephropathy, Glomerular Disease, IgAN | 05/23 | 06/23 | | |
ChiCTR2200063329: A Randomized, Open-label, Phase 1 Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects |
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| Not yet recruiting | 1 | 24 | | 200 mg Sibeprenlimab (1 × 1 mL injection) ;400 mg Sibeprenlimab (1 × 2 mL injection) ;600 mg Sibeprenlimab (1 × 1 mL injection and 1 × 2 mL injection) | West China Hospital of Sichuan University; Otsuka Pharmaceutical Development & Commercialization, Inc, Otsuka Pharmaceutical Development & Commercialization, Inc | health Subjects | | | | |
