Back to resultsVisionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)
Primary Purpose
Immunoglobulin A Nephropathy
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sibeprenlimab 400 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Immunoglobulin A Nephropathy focused on measuring IgAN, Sibeprenlimab, VIS649
Eligibility Criteria
Inclusion Criteria:
- Male and female patients ≥ 18 years of age .
- Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
- Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
- Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
- eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the CKD-EPI equation.)
Exclusion Criteria:
- Secondary forms of IgAN or IgA vasculitis.
- Coexisting chronic kidney disease other than IgAN.
- Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
- Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
- Nephrotic syndrome
- Serum IgG < 600 mg/dL at screening.
- Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
- Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
- Chronic infectious disease, or acute infectious disease at time of screening.
- Type 1 diabetes, or poorly controlled Type 2 diabetes
- Uncontrolled hypertension
The protocol provides additional information about these and other inclusion and exclusion criteria.
Sites / Locations
- For additional information regarding sites, contact 844-687-8522Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sibeprenlimab 400 mg s.c. q 4weeks
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
Secondary Outcome Measures
Annualized rate of change from baseline (slope) of eGFR
Proportion of subjects achieving urine total protein < 1.0 g/day and ≥ 25% reduction from baseline.
Annualized slope of eGFR
Full Information
NCT ID
NCT05248646
First Posted
February 18, 2022
Last Updated
October 11, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05248646
Brief Title
Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 3 study to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q 4 weeks compared to placebo in patients with IgAN. The primary objective is to compare the relative change from baseline in the urinary protein to creatinine ratio (uPCR) in 24-hour urine collections, after 9 months of treatment. The key secondary objective is to compare the annualized rate of change from baseline (slope) of estimated glomerular filtration rate (eGFR) after approximately 24 months of treatment. There will be one main cohort comprised of approximately 450 subjects with source-verified biopsy-confirmed IgAN and eGFR ≥ 30 mL/min/1.73 m^2. An additional exploratory cohort will be comprised of up to 20 subjects with source-verified biopsy confirmed IgAN and eGFR of 20 to < 30 mL/min/1.73 m^2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunoglobulin A Nephropathy
Keywords
IgAN, Sibeprenlimab, VIS649
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
470 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sibeprenlimab 400 mg s.c. q 4weeks
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sibeprenlimab 400 mg
Other Intervention Name(s)
VIS649
Intervention Description
Sibeprenlimab 400 mg s.c. q 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo s.c. q 4 weeks
Primary Outcome Measure Information:
Title
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
Time Frame
At 9 months
Secondary Outcome Measure Information:
Title
Annualized rate of change from baseline (slope) of eGFR
Time Frame
Over 24 months
Title
Proportion of subjects achieving urine total protein < 1.0 g/day and ≥ 25% reduction from baseline.
Time Frame
At 12 months
Title
Annualized slope of eGFR
Time Frame
Over 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients ≥ 18 years of age .
Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the CKD-EPI equation.)
Exclusion Criteria:
Secondary forms of IgAN or IgA vasculitis.
Coexisting chronic kidney disease other than IgAN.
Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
Nephrotic syndrome
Serum IgG < 600 mg/dL at screening.
Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
Chronic infectious disease, or acute infectious disease at time of screening.
Type 1 diabetes, or poorly controlled Type 2 diabetes
Uncontrolled hypertension
The protocol provides additional information about these and other inclusion and exclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Otsuka Call Center
Phone
844-687-8522
Email
OtsukaRMReconciliation@rmpdc.org
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
Individual Site Status
Recruiting
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
https://clinical-trials.otsuka.com
Learn more about this trial
Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)
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