VB119 for Kidney Disease

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

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment called VB119 to see if it is safe and effective. It focuses on people with a kidney condition called primary MN. Researchers want to understand how VB119 works in the body and if it can help these patients.

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.

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+