Unknown Brain & Nervous System NIHR-supported project Lungs & Breathing

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

Funder NIHR (part of DHSC)
Recipient organisation NIHR Wellcome Trust Cambridge Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Feb 2025 — Ongoing

In plain English

AI plain-English summary

Patients who have been taking the experimental drug atacicept in clinical trials for IgA nephropathy will be allowed to continue receiving it for up to three more years in this rollover study, rather than losing access when the initial trial ends. IgA nephropathy is a chronic kidney disease where immune protein deposits build up in the kidneys’ filters, gradually causing inflammation, scarring, and loss of function. Many patients eventually need dialysis or a transplant. Current treatments—blood pressure control and immune-suppressing drugs—are limited and often insufficient. Atacicept works by reducing the production of the problematic IgA antibodies. This Phase 2 study tracks long-term safety and tolerability in two groups: those restarting atacicept after a pause, and those continuing without interruption. If atacicept proves safe and effective over years of use, it could become a new treatment option that slows or halts kidney decline in IgA nephropathy patients, potentially delaying or preventing the need for dialysis or transplantation. That would directly improve quality of life for thousands of people with this condition and reduce long-term healthcare costs for kidney failure management.

View original technical description
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.

Researchers

Lisa Willcocks (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)
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 A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)
ORIGIN 3 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)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.