ORIGIN EXTEND

• Research type

  Research Study

• Full title

  A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept

• IRAS ID

  1010892

• Contact name

  Erin Collins

• Contact email

  Regulatory@VeraTx.com

• Sponsor organisation

  Vera Therapeutics, Inc.

• Eudract number

  2024-516380-81

• Research summary

  Immunoglobulin (Ig) A nephropathy (IgAN) or Berger’s disease, is a chronic kidney disorder that occurs when Immunoglobulin A (IgA) builds up in the glomeruli (filters) of the kidney. Over time, these IgA deposits can inflame, damage and scar the glomeruli, causing leakage of blood and protein into the urine. Ultimately IgAN patients may go on to lose kidney function and may require a kidney transplant or dialysis.
  There is a significant unmet medical need for the treatment of IgAN. Current management includes blood pressure control, renin-angiotensin system (RAS) blockade and in rare instances combination immunosuppression with cyclophosphamide and corticosteroids for rapidly progressive IgAN. Atacicept is thought to help regulate the immune system by reducing and blocking plasma cells and B-cells from producing IgA. Atacicept is currently being evaluated in clinical trials and is not commercially available. Once participants complete the protocol-defined treatment-period of these trials, they no longer have access to atacicept within the clinical trial. This Phase 2 study will allow participants with IgAN to continue to receive atacicept 150 mg once weekly self-administered subcutaneously. The main study endpoint is:
  the long-term safety and tolerability of Atacicept. Participants will be grouped by whether they are restarting atacicept after cessation in the parent study (Group 1, Atacicept Drug Holiday) or are continuing atacicept with no disruption in study treatment (Group 2: Continuous Atacicept Treatment). The first dose of atacicept in this rollover study is defined as Day 1 and should not occur prior to the completion of the protocol-defined treatment period of the parent study. Participants will be treated in this study for up to 3 years but could end treatment in this study once atacicept is commercially available in their country/region or if the Sponsor terminates the clinical development program.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  24/ES/0094

• Date of REC Opinion

  22 Jan 2025

• REC opinion

  Further Information Favourable Opinion