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

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ClinicalTrials.gov Identifier: NCT05441826
Recruitment Status : Recruiting
First Posted : July 1, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
ValenzaBio, Inc.

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.

Condition or disease Intervention/treatment Phase
Minimal Change Disease Focal Segmental Glomerulosclerosis Drug: VB119 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 3, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : February 28, 2024


Arm Intervention/treatment
Experimental: VB119
VB119 100 or 200mg IV doses administered 4 times
Drug: VB119
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.




Primary Outcome Measures :
  1. The proportion of subjects in remission at End of Treatment [ Time Frame: Day 274 ]
    Efficacy

  2. Incidence of serious adverse events (SAEs) [ Time Frame: through Day 420 ]
    Safety and Tolerability

  3. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: through Day 420 ]
    Safety and Tolerability

  4. Incidence of adverse events of special interest (AESIs) [ Time Frame: through Day 420 ]
    Safety and Tolerability


Secondary Outcome Measures :
  1. Change in UPCR [ Time Frame: Multiple timepoints from Day 1 to Day 337 ]
    Efficacy

  2. Change in eGFR [ Time Frame: Multiple timepoints from Screening to Day 337 ]
    Efficacy

  3. Proportion of subjects that are recurrence-free [ Time Frame: From Day 1 to Day 337 ]
    Efficacy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05441826


Contacts
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Contact: Project Director (301) 755-9900 clinicaltrials@valenzabiotech.com

Locations
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United States, California
ValenzaBio Investigative Site Recruiting
Los Angeles, California, United States, 91324
ValenzaBio Investigative Site Recruiting
Tarzana, California, United States, 91356
United States, Florida
ValenzaBio Investigative Site Recruiting
Tampa, Florida, United States, 33603
United States, Nevada
ValenzaBio Investigative Site Recruiting
Reno, Nevada, United States, 89511
United States, New York
ValenzaBio Investigative Site Recruiting
Albany, New York, United States, 12208
United States, North Carolina
ValenzaBio Investigative Site Recruiting
Greenville, North Carolina, United States, 27858
United States, Texas
ValenzaBio Investigative Site Recruiting
Dallas, Texas, United States, 75237
United States, Utah
ValenzaBio Investigative Site Recruiting
Salt Lake City, Utah, United States, 84115
Sponsors and Collaborators
ValenzaBio, Inc.
Investigators
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Study Chair: Keenan ValenzaBio, Inc.
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Responsible Party: ValenzaBio, Inc.
ClinicalTrials.gov Identifier: NCT05441826    
Other Study ID Numbers: 119-02-02
First Posted: July 1, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Nephrosis, Lipoid
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Nephrosis