Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)
Primary Purpose
Minimal Change Disease, Focal Segmental Glomerulosclerosis
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VB119
Sponsored by
About this trial
This is an interventional treatment trial for Minimal Change Disease
Eligibility Criteria
Inclusion Criteria:
- Is ≥ 18 years of age at the time of informed consent;
- Kidney biopsy-proven diagnosis of primary MCD or primary FSGS within the past 10 years. Subjects with kidney biopsy-proven diagnosis of primary MCD or primary FSGS greater than 10 years and less than 20 years prior to Screening who meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor
- History of steroid-sensitive MCD or FSGS, defined as having achieved complete remission of proteinuria (reduction of proteinuria to <0.5 g/g UPCR) after use of corticosteroids;
- Has experienced meaningful proteinuria in the last 2 years prior to Screening, defined as UPCR >2.0 g/g, after attempted or completed tapering of steroids and/or CNIs that occurs within 6 months of the attempt or completion of tapering;
- Currently on prednisone regimen at time of Screening and anticipated to be tapered to a stable dose of prednisone of no more than 20 mg/day for at least 14 days prior to Day 1
- Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;
- Is willing and able to provide written informed consent prior to Screening;
- Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the central laboratory's ranges;
- Female subjects of childbearing potential (ie, ovulating, premenopausal, or not surgically sterile) and all male subjects must use a medically accepted, highly effective contraceptive regimen during their participation in the study and for 125 days (4 months) after the last administration of study drug.
- Male subjects must agree to abstain from sperm donation through 125 days (4 months) after administration of the last dose of study drug.
Exclusion Criteria:
- Has an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney DiseaseEpidemiology Collaboration formula confirmed by the central laboratory;
- Has an absolute neutrophil count <1.5 x 10/L;
- Has a white blood cell count <3.0 x 10/L;
- Has secondary causes of MCD or FSGS (eg, malignancy, hepatitis B or C, human immunodeficiency virus [HIV], systemic lupus erythematosus [SLE], or other autoimmune diseases [eg, thyroiditis], drug-induced);
- Has a diagnosis or history of SLE (including non renal disease);
- Has type 1 or 2 diabetes mellitus;
- Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infection.
Sites / Locations
- Clinical Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VB119
Arm Description
VB119 100 or 200mg IV doses administered 4 times
Outcomes
Primary Outcome Measures
The proportion of subjects in remission at End of Treatment
Efficacy
Incidence of serious adverse events (SAEs)
Safety and Tolerability
Incidence of treatment-emergent adverse events (TEAEs)
Safety and Tolerability
Incidence of adverse events of special interest (AESIs)
Safety and Tolerability
Secondary Outcome Measures
Change in UPCR
Efficacy
Change in eGFR
Efficacy
Proportion of subjects that are recurrence-free
Efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05441826
Brief Title
Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)
Official Title
A Phase 2 Study of VB119 in Adult Subjects With Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
June 13, 2023 (Anticipated)
Study Completion Date
November 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACELYRIN 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
Phase 2, multi-center, proof-of-concept study to evaluate the safety and efficacy of VB119 on the maintenance of remission and duration of response in adults with primary MCD or primary FSGS who previously responded to steroid therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Change Disease, Focal Segmental Glomerulosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VB119
Arm Type
Experimental
Arm Description
VB119 100 or 200mg IV doses administered 4 times
Intervention Type
Drug
Intervention Name(s)
VB119
Intervention Description
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.
Primary Outcome Measure Information:
Title
The proportion of subjects in remission at End of Treatment
Description
Efficacy
Time Frame
Day 274
Title
Incidence of serious adverse events (SAEs)
Description
Safety and Tolerability
Time Frame
through Day 420
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Safety and Tolerability
Time Frame
through Day 420
Title
Incidence of adverse events of special interest (AESIs)
Description
Safety and Tolerability
Time Frame
through Day 420
Secondary Outcome Measure Information:
Title
Change in UPCR
Description
Efficacy
Time Frame
Multiple timepoints from Day 1 to Day 337
Title
Change in eGFR
Description
Efficacy
Time Frame
Multiple timepoints from Screening to Day 337
Title
Proportion of subjects that are recurrence-free
Description
Efficacy
Time Frame
From Day 1 to Day 337
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is ≥ 18 years of age at the time of informed consent;
Kidney biopsy-proven diagnosis of primary MCD or primary FSGS within the past 10 years. Subjects with kidney biopsy-proven diagnosis of primary MCD or primary FSGS greater than 10 years and less than 20 years prior to Screening who meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor
History of steroid-sensitive MCD or FSGS, defined as having achieved complete remission of proteinuria (reduction of proteinuria to <0.5 g/g UPCR) after use of corticosteroids;
Has experienced meaningful proteinuria in the last 2 years prior to Screening, defined as UPCR >2.0 g/g, after attempted or completed tapering of steroids and/or CNIs that occurs within 6 months of the attempt or completion of tapering;
Currently on prednisone regimen at time of Screening and anticipated to be tapered to a stable dose of prednisone of no more than 20 mg/day for at least 14 days prior to Day 1
Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;
Is willing and able to provide written informed consent prior to Screening;
Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the central laboratory's ranges;
Female subjects of childbearing potential (ie, ovulating, premenopausal, or not surgically sterile) and all male subjects must use a medically accepted, highly effective contraceptive regimen during their participation in the study and for 125 days (4 months) after the last administration of study drug.
Male subjects must agree to abstain from sperm donation through 125 days (4 months) after administration of the last dose of study drug.
Exclusion Criteria:
Has an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney DiseaseEpidemiology Collaboration formula confirmed by the central laboratory;
Has an absolute neutrophil count <1.5 x 10/L;
Has a white blood cell count <3.0 x 10/L;
Has secondary causes of MCD or FSGS (eg, malignancy, hepatitis B or C, human immunodeficiency virus [HIV], systemic lupus erythematosus [SLE], or other autoimmune diseases [eg, thyroiditis], drug-induced);
Has a diagnosis or history of SLE (including non renal disease);
Has type 1 or 2 diabetes mellitus;
Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keenan
Organizational Affiliation
ValenzaBio, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)
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