VB119 for Kidney Disease

Not currently recruiting at 29 trial locations

Overseen By Paul Peloso, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ACELYRIN Inc.

Disqualifiers: Diabetes, Lupus, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VB119 to determine its safety and effectiveness for individuals with primary membranous nephropathy (MN). The study administers VB119 through IV infusions and observes the body's response to different doses. It seeks participants with a confirmed diagnosis of primary MN within the last 10 years who have experienced significant protein in their urine. This trial does not suit individuals with certain other health conditions, such as diabetes or lupus. As a Phase 1 trial, the research focuses on understanding how VB119 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that VB119 is likely to be safe for humans?

Research has shown that VB119 is undergoing tests to ensure its safety and effectiveness in treating kidney disease. Early results are promising, with some patients showing improvements in health indicators, such as reduced protein in their urine. This suggests the treatment is effective and not causing serious side effects.

However, since VB119 remains in early testing stages, complete safety information is not yet available. The study examines different doses to determine the safest and most effective amount. So far, no major safety issues have emerged, but the full safety profile is still being developed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about VB119 for kidney disease because it offers a novel approach by using a monoclonal antibody to target the complement system, which plays a key role in inflammation and kidney damage. Unlike standard treatments like ACE inhibitors or corticosteroids that mainly address symptoms or general inflammation, VB119 aims to directly interfere with the underlying disease mechanism. This targeted action could potentially lead to better outcomes with fewer side effects, making it a promising option for patients.

What evidence suggests that VB119 might be an effective treatment for kidney disease?

Research has shown that VB119, which participants in this trial will receive, may help treat kidney disease, particularly primary membranous nephropathy (MN). In one study, three out of four patients experienced a rapid reduction in excess protein in their urine within a month of starting VB119 treatment. Patients who improved by at least 25% in six months could continue with further treatment, indicating ongoing benefits. These early results suggest that VB119 could effectively lower protein levels in urine, a major concern in primary MN. ^{1 2 5 6 7}

Who Is on the Research Team?

Keenan

Principal Investigator

ValenzaBio, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with a confirmed diagnosis of primary Membranous Nephropathy (kidney disease) within the last 10 years, showing high levels of protein in urine. Participants must have stable blood pressure and agree to use effective contraception. Those with certain infections, diabetes, low white blood cell counts, or other autoimmune diseases like lupus are excluded.

Inclusion Criteria

Has a documented laboratory history of nephrotic range proteinuria (defined as either greater than or equal to 3.5 g total protein per 24-hour urine collection or greater than or equal to 3.5 g/g UPCR by spot collection) AND has proteinuria with a UPCR greater than or equal to 2.0 g/g based on 2 consecutive spot urine (first morning void) sample collections obtained within 14 days of each other during the Screening Period. Both samples must qualify.

I am using effective birth control and will continue for 125 days after the last study drug dose.

I was diagnosed with primary membranous nephropathy through a kidney biopsy in the last 10 years.

Exclusion Criteria

My kidney function is reduced, with an eGFR below 45.

Has an absolute neutrophil count <1.5 x 10/L

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of VB119 to evaluate safety and tolerability

6 months

Regular visits for dose administration and monitoring

Dose Expansion

Participants receive expanded doses of VB119 to further evaluate safety and efficacy

6 months

Regular visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• VB119

Trial Overview The study tests VB119's safety and effectiveness on kidney function in patients with Membranous Nephropathy. It's an early-stage trial where doses increase over time among different groups to find the right balance between benefits and side effects.

How Is the Trial Designed?

Group I: VB119 dose escalation Experimental Treatment 1 Intervention

Dose escalation phase followed by a dose expansion phase. VB119 to be administered as intravenous infusions.

Who Is Running the Clinical Trial?

ACELYRIN Inc.

Lead Sponsor

Trials

9

Recruited

1,100+

Tenet Medicines

Lead Sponsor

Trials

3

Recruited

7+

ValenzaBio, Inc.

Lead Sponsor

Trials

3

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04652570

NCT04652570 | Efficacy and Safety of VB119 in Subjects ... Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

2. asn-online.org asn-online.org/education/kidneyweek/2022/program-abstract.aspx?controlId=3765403

Kidney Week Participants with ≥ a 25% improvement in proteinuria at 6 months are eligible to receive a subsequent cycle of VB119. Laboratory monitoring includes B-Cell ...

3. firstwordpharma.com firstwordpharma.com/story/5671188

ValenzaBio Announces Positive Preliminary Data from ... Three of four evaluable patients had rapid reduction in proteinuria less than one month after initiation of therapy.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11044666/

An Updated Review of Membranous Nephropathy In recent groundbreaking randomized clinical trials, dapagliflozin and empagliflozin improved proteinuria and decelerated eGFR decline in patients with ...

5. ajkd.org ajkd.org/article/S0272-6386(23)00838-7/pdf

Ofatumumab in Rituximab-Resistant and ... This treatment may also result in NS remission in a fraction of patients who are resistant to rituximab, who often expe- rience progression to ...

6. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/a-phase-1b2a-study-of-vb119-in-adult-subjects-with-primary-mn/

* A Phase 1b/2a Study of VB119 in Adult Subjects with ... The purpose of this study is to learn about the effects of a study drug, VB119, to find the best dose for possibly treating MN.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11595011/

Detailed Pathophysiology of Minimal Change Disease This long-term steroid use is associated with numerous adverse effects, including growth retardation, osteoporosis, obesity, hypertension, and ...