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

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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Immunoglobulin A Nephropathy
• Intervention / Treatment: Drug: Sibeprenlimab 400 mg s.c. Q4weeks

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.

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

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Otsuka Call Center; Phone Number: 844-687-8522; Email: visionary@otsuka-us.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • For additional information regarding sites, contact 844-687-8522

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sibeprenlimab 400 mg s.c. q 4 weeks	Drug: Sibeprenlimab 400 mg s.c. Q4weeks; Sibeprenlimab 400 mg s.c. q 4 weeks; Other Names: VIS649

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	From baseline to the end-of-trial visit in Week 112.

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Proportion of Subjects with Clinical Remission as defined in the protocol	At 12 and 24 months
Time to Progression of Chronic Kidney Disease, as defined in the protocol	Over 24 months

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Estimated): December 28, 2028
• Study Completion (Estimated): December 28, 2028

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: IgAN; VIS649; Sibeprenlimab
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: 417-201-00012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No