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

• Status: Not yet recruiting
• Trial end date: 2028-12-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

Inclusion Criteria:

• Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.

• eGFR ≥ 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion Criteria:

• Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.

• Subjects who, following enrollment in trials 417-201-00007 or VIS649-201 developed a condition or characteristic that would have excluded them from participation in these trials.