ORIGIN 3
Research type
Research Study
Full title
A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) (ORIGIN 3)
IRAS ID
1008932
Contact name
Ashley Rhoades
Contact email
Sponsor organisation
Vera Therapeutics, Inc.
Eudract number
2023-503772-24
Clinicaltrials.gov Identifier
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.VT-001 (also known as Atacicept) is thought to help regulate the immune system by reducing and blocking plasma cells and B-cells from producing IgA.
This is a multi-part study comprising of the original Phase 2b study (ORIGIN) and the addition of a separate Phase 3 study (ORIGIN 3). The Phase 3 study is a multicenter, randomized, double-blind, placebo-controlled trial. The objectives of the Phase 3 study will be to determine the effect of atacicept on proteinuria and preservation of renal function in subjects with IgAN.
The study is composed of a (up to) 4-week Screening Period, a 104-week Double-Blind Treatment Period (Part C), a 52-week Open-Label Extension (Part D) and 26 weeks of follow-up. Subjects who complete the 104-week Double-Blind Period on treatment will be eligible for open-label atacicept 150 mg for an additional 52 weeks (Open-Label Extension).
Approximately 376 randomized participants will be recruited from up to 250 research centers globally. The study is sponsored by Vera Therapeutics, Inc.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0259
Date of REC Opinion
21 Dec 2023
REC opinion
Further Information Favourable Opinion