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Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

Immunoglobulin A Nephropathy Clinical Trial

Official title:
A Phase 2/3, Multicenter, Open-label Extension Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Clinical Trial Summary

This is a phase 2/3 open-label study to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.

Clinical Trial 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. Subjects who have not previously received sibeprenlimab will not be enrolled in this trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05248659
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Enrolling by invitation
Phase Phase 2/Phase 3
Start date April 5, 2022
Completion date December 28, 2028
View Details
See also
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