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VB119 for Membranous Glomerulonephritis

Phase 1 & 2

Waitlist Available

Research Sponsored by ACELYRIN Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a kidney biopsy-proven diagnosis of primary MN within the past 10 years

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 after the last administration of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 18 months

Awards & highlights

Study Summary

This trial is testing a new drug, VB119, to see if it is safe and effective for people with a certain type of cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects for VB119 aren't listed here but may include typical drug reactions such as nausea, allergic responses, potential impact on blood cells or organ functions which will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am a woman who cannot have children due to surgery or being postmenopausal for 2+ years.

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I agree not to donate sperm for 125 days after my last dose of the study drug.

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I am 18 years old or older.

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My kidney biopsy shows positive for anti-PLA2R and my primary MN diagnosis was between 10 and 20 years ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Clinical Laboratory Assessments

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

% of Patients with Anti-Drug Antibodies

% of patients achieving complete remission of proteinuria

Anti-PLA2R Antibody Assessment

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: VB119 dose escalationExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

ACELYRIN Inc.Lead Sponsor

8 Previous Clinical Trials

1,052 Total Patients Enrolled

Tenet MedicinesLead Sponsor

1 Previous Clinical Trials

1 Total Patients Enrolled

ValenzaBio, Inc.Lead Sponsor

2 Previous Clinical Trials

39 Total Patients Enrolled

Media Library

VB119 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04652570 — Phase 1 & 2

Membranous Glomerulonephritis Research Study Groups: VB119 dose escalation

Membranous Glomerulonephritis Clinical Trial 2023: VB119 Highlights & Side Effects. Trial Name: NCT04652570 — Phase 1 & 2

VB119 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04652570 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to join this experiment?

"Affirmative. Clinicaltrials.gov's data shows that the clinical trial, initially posted on May 5th 2021, is presently recruiting patients for participation. 30 participants need to be admitted across 19 medical centres."

Answered by AI

How many healthcare facilities are offering participation in this clinical experiment?

"There are presently 19 sites offering this trial, including locations in Los Angeles, San Antonio and Pontiac. To limit travel needs if you decide to take part, it is advisable to choose the closest centre of research."

Answered by AI

How many participants are enrolled in this investigation?

"Affirmative. The details on clinicaltrials.gov demonstrate that this medical experiment is presently enrolling participants, with the initial post having been made on May 5th 2021 and last updated July 19th 2022. Thirty patients need to be recruited from 19 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

2021. "Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04652570.