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

Last updated: December 4, 2024
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Active - Enrolling

Phase

2/3

Condition

Glomerulonephritis

Treatment

Sibeprenlimab 400 mg s.c. Q4weeks

Clinical Study ID

NCT05248659
417-201-00012
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

Exclusion

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 acondition or characteristic that would have excluded them from participation inthese trials.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Sibeprenlimab 400 mg s.c. Q4weeks
Phase: 2/3
Study Start date:
April 05, 2022
Estimated Completion Date:
December 28, 2028

Study 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.

Connect with a study center

  • For additional information regarding sites, contact 844-687-8522

    New York, New York 10001
    United States

    Site Not Available

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