* A Phase 1b/2a Study of VB119 in Adult Subjects with Primary MN
Research type
Research Study
Full title
A Phase 1b/2a Study of VB119 in Adult Subjects with Primary Membranous Nephropathy
IRAS ID
297859
Contact name
Lisa Willcocks
Contact email
Sponsor organisation
Medpace
Eudract number
2020-004820-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Primary membranous nephropathy (MN), is a disease which causes the body to lose a lot of protein in the urine (called proteinuria) and can cause a decline in kidney function over time. The disease is caused by the immune system forming antibodies that damage the kidneys.
ValenzaBio, Inc., the study sponsor, is developing VB119 as a treatment for MN. VB119 works by lowering the activity of certain parts of the body’s own immune system that may be causing it to harm the kidneys and release protein in the urine.
This is a phase 1b/2a, dose escalation and dose expansion study. 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 in order to try decrease the amount of protein being lost in urine, and to see how safe VB119 is for MN patients.
All study participants will receive VB119. In the dose escalation phase, participants will receive either 2 bi-weekly or 4 weekly doses of VB119 at the specified dose level, administered via intravenous infusion. In the first group, participants will receive the lowest dose of 100mg VB119 bi-weekly for 2 doses. A safety committee will review safety data and the effects of the study drug on the immune system and then determine if the next groups can receive higher doses and/or 4 weekly doses instead of 2 bi-weekly doses. The highest possible dose group would receive doses of 400mg. Each participant may also receive 2 additional bi-weekly doses at 6 months if pre-defined criteria are met.
The total study duration for each participant will be <86 weeks, including the screening, treatment period and follow-up visits. About 30 participants will take part in this study at approximately 15 sites in the US and UK.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0303
Date of REC Opinion
24 Jun 2021
REC opinion
Further Information Favourable Opinion