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.

Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country600 target enrollmentApril 5, 2022

ConditionsImmunoglobulin A Nephropathy

InterventionsSibeprenlimab 400 mg s.c. Q4weeks

DrugsSibeprenlimab 400 mg s.c. Q4weeks

Overview

Phase: Phase 2
Intervention: Sibeprenlimab 400 mg s.c. Q4weeks
Conditions: Immunoglobulin A Nephropathy
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 600
Locations: 1
Primary Endpoint: Adverse Events
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

April 5, 2022

End Date

December 28, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party

Sponsor

Eligibility 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-
•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.

Arms & Interventions

Sibeprenlimab 400 mg s.c. q 4 weeks

Intervention: Sibeprenlimab 400 mg s.c. Q4weeks

Outcomes

Primary Outcomes

Adverse Events

Time Frame: From baseline to the end-of-trial visit in Week 112.

Secondary Outcomes

Time to Progression of Chronic Kidney Disease, as defined in the protocol(Over 24 months)
Proportion of Subjects with Clinical Remission as defined in the protocol(At 12 and 24 months)
Annualized slope of Estimated Glomerular Filtration Rate (eGFR)(Over 12 and 24 months)
Urine protein/creatinine ratio (uPCR) in a 24-hour collection(At 12 and 24 months)