Atacicept in Multiple Glomerular Diseases

• Research type

  Research Study

• Full title

  A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER).

• IRAS ID

  1012158

• Contact name

  Jigisha Shah

• Contact email

  jigisha.shah@veratx.com

• Sponsor organisation

  Vera Therapeutics Inc.

• Eudract number

  2024-518465-10

• Research summary

  The PIONEER study is a basket study (that is, a study designed to address multiple diseases) seeking to determine how well the study drug atacicept works and how safe it is in participants with multiple kidney diseases where the immune system attacks the body. These conditions include IgA nephropathy (IgAN), IgA vasculitis with nephritis (IgAVN), Primary membranous nephropathy (pMN) and Minimal change disease and focal segmental glomerular sclerosis (MCD and FSGS).

  Approximately 200 participants (up to 120 IgAN or IgAVN, 40 pMN, and 40 MCD/FSGS) will take part in this study at approx. 75 study sites in Europe, North America, and Australia. Participation in this study will include 4 week screening period, treatment period of 52 weeks (approx. 12mths/1yr) with study drug. and 2 follow-up visits within 26 weeks after stopping the study drug (approximately 11 study visits to the study site.)

• REC name

  Wales REC 3

• REC reference

  25/WA/0183

• Date of REC Opinion

  30 Jul 2025

• REC opinion

  Further Information Favourable Opinion