clinical trial · NCT05248659
Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
Otsuka Pharmaceutical Development & Commercialization, Inc.·phase3·enrolling by invitation·n = 600
Immunoglobulin A NephropathySibeprenlimab 400 mg s.c. Q4weeks
brief summary
This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.
started
Apr 5, 2022
primary completion
Dec 28, 2028
completion
Dec 28, 2028
last updated
Dec 9, 2024
detailed description
This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.
Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.
official title
A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol