Ph3, Open-label to Evaluate Efficacy and Safety of Zanubrutinib in Primary Membranous Nephropathy
Research type
Research Study
Full title
A Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous Nephropathy
IRAS ID
1006748
Contact name
Kajal Patel
Contact email
Sponsor organisation
BeiGene Ltd
Eudract number
2022-501147-32
Research summary
Primary membranous nephropathy is a rare kidney damaging disease in Europe and the USA. B-cell dysfunction (when white blood cells are unable to produce infection-fighting proteins called antibodies) plays a key role in the development of primary membranous nephropathy, and B cell-targeting treatment can induce clinical remission (when signs and symptoms of the disease are mostly absent and/or resolved). Bruton tyrosine kinase (BTK) is a molecule that plays an important role in the biological function of B cells. As a BTK inhibitor, Zanubrutinib (BGB-3111) may be effective in treating patients with PMN, thereby inducing clinical remission. Duration of treatment would be 1 year and 3 months with an observation period of 9 months thereafter.
There are two parts to this study.
Part 1 will be an evaluation of the effectiveness and safety of Zanubrutinib in patients with PMN.
Part 2 will be a randomised evaluation of the effectiveness of Zanubrutinib compared with Tacrolimus and an evaluation of the safety of Zanubrutinib in participants with PMN who are on optimal supportive care (participants managing their disease related symptoms only). The Sponsor for this trial is BeiGene Ltd.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0023
Date of REC Opinion
10 Sep 2023
REC opinion
Further Information Favourable Opinion