Olympus
Research type
Research Study
Full title
A Phase 2b/3 Adaptive, Randomized, Active-controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy
IRAS ID
1012868
Contact name
Sarah Fish
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2025-521661-27
Research summary
This study is testing if a new medicine called povetacicept can help people with a rare kidney disease called primary Membranous Nephropathy (pMN). In pMN, the body's immune system attacks the kidneys, causing protein to leak into urine (pee). This can make people sick and stop the kidneys from working. Current treatments don't work for everyone, so more effective treatment options are needed.
The study has two parts:
1. Phase 2b: people participating in this part of the study will receive povetacicept . Povetacicept is given as an injection under the skin, once every 4 weeks.
Researchers will choose which dose of povetacicept will be used in the next part of the study.
Phase 3: in this part of the study, povetacicept will be compared to a standard treatment for pMN.
The goal is to see if povetacicept is safe and works better than current treatments for pMN. Participants will be monitored for side effects and improvements in their condition.
In total, around 176 people will participate in this study across multiple countries. Vertex Pharmaceuticals is running the study.REC name
London - City & East Research Ethics Committee
REC reference
25/LO/0712
Date of REC Opinion
23 Oct 2025
REC opinion
Further Information Favourable Opinion