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 Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05248659
• Other study ID #: 417-201-00012
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: April 5, 2022
• Est. completion date: December 28, 2028

Study information

• Verified date: October 2023
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: December 28, 2028
• Est. primary completion date: December 28, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• Immunoglobulin A Nephropathy
• Kidney Diseases

Intervention

Drug:
• Sibeprenlimab 400 mg s.c. Q4weeks
Sibeprenlimab 400 mg s.c. q 4 weeks

Locations

Country	Name	City	State
United States	For additional information regarding sites, contact 844-687-8522	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		From baseline to the end-of-trial visit in Week 112.
Secondary	Annualized slope of Estimated Glomerular Filtration Rate (eGFR)		Over 12 and 24 months
Secondary	Urine protein/creatinine ratio (uPCR) in a 24-hour collection		At 12 and 24 months
Secondary	Proportion of Subjects with Clinical Remission as defined in the protocol		At 12 and 24 months
Secondary	Time to Progression of Chronic Kidney Disease, as defined in the protocol		Over 24 months