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

Primary Purpose

Immunoglobulin A Nephropathy

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sibeprenlimab 400 mg s.c. Q4weeks
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunoglobulin A Nephropathy focused on measuring Sibeprenlimab, VIS649, IgAN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sibeprenlimab 400 mg s.c. q 4 weeks

Arm Description

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2022
Last Updated
October 11, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05248659
Brief Title
Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
December 28, 2028 (Anticipated)
Study Completion Date
December 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunoglobulin A Nephropathy
Keywords
Sibeprenlimab, VIS649, IgAN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sibeprenlimab 400 mg s.c. q 4 weeks
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sibeprenlimab 400 mg s.c. Q4weeks
Other Intervention Name(s)
VIS649
Intervention Description
Sibeprenlimab 400 mg s.c. q 4 weeks
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
From baseline to the end-of-trial visit in Week 112.
Secondary Outcome Measure Information:
Title
Annualized slope of Estimated Glomerular Filtration Rate (eGFR)
Time Frame
Over 12 and 24 months
Title
Urine protein/creatinine ratio (uPCR) in a 24-hour collection
Time Frame
At 12 and 24 months
Title
Proportion of Subjects with Clinical Remission as defined in the protocol
Time Frame
At 12 and 24 months
Title
Time to Progression of Chronic Kidney Disease, as defined in the protocol
Time Frame
Over 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 VIS649-201. 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.
Facility Information:
Facility Name
For additional information regarding sites, contact 844-687-8522
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://clinical-trials.otsuka.com

Learn more about this trial

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

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