Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)

Focal Segmental Glomerulosclerosis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05441826
• Other study ID #: 119-02-02
• Status: Terminated
• Phase: Phase 2
• Start date: May 3, 2022
• Est. completion date: October 12, 2023

Study information

• Verified date: April 2024
• Source: Tenet Medicines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 12, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is = 18 years of age at the time of informed consent;

2. 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

3. 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;

4. 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;

5. 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

6. Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;

7. Is willing and able to provide written informed consent prior to Screening;

8. 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;

9. 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.

10. 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:

1. 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;

2. Has an absolute neutrophil count <1.5 x 10/L;

3. Has a white blood cell count <3.0 x 10/L;

4. 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);

5. Has a diagnosis or history of SLE (including non renal disease);

6. Has type 1 or 2 diabetes mellitus;

7. Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infection.

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis
• Glomerulosclerosis, Focal Segmental
• Minimal Change Disease
• Nephrosis, Lipoid

Intervention

Drug:
• VB119
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.

Locations

Country	Name	City	State
United States	Clinical Research Site	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tenet Medicines

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects in remission at End of Treatment	Efficacy	Day 274
Primary	Incidence of serious adverse events (SAEs)	Safety and Tolerability	through Day 420
Primary	Incidence of treatment-emergent adverse events (TEAEs)	Safety and Tolerability	through Day 420
Primary	Incidence of adverse events of special interest (AESIs)	Safety and Tolerability	through Day 420
Secondary	Change in UPCR	Efficacy	Multiple timepoints from Day 1 to Day 337
Secondary	Change in eGFR	Efficacy	Multiple timepoints from Screening to Day 337
Secondary	Proportion of subjects that are recurrence-free	Efficacy	From Day 1 to Day 337