The investigational study medication, atacicept, is a subcutaneous injection (injection given under the skin) given once weekly.
It is designed to target the two overactivated immune cells, B cells and plasma cells, that cause the overproduction of an abnormal antibody called galactose-deficient IgA1 (Gd-IgA1).
By blocking new targets in the immune response that causes IgAN, atacicept could prevent kidney damage and slow the progression of disease.
Yes: to date, over 1,500 people have received at least one dose of atacicept in clinical studies across various indications within and outside the U.S. Atacicept has been well-tolerated in these studies, with similar side effects to placebo.
An early clinical study with atacicept showed potential benefit for patients with IgAN, including the reduction of the abnormal antibody Gd-IgA1. In the Phase 2b portion of the ORIGIN study, atacicept was evaluated in 116 people with IgAN. The participants who received atacicept had greater reductions in the amount of protein in their urine, which may indicate improved kidney function.
The ORIGIN 3 study will use the same formulation and dose of atacicept that was used in the early clinical study.
In this study, participants will receive either the investigational medication or the placebo (a placebo has no active ingredients), in addition to continuing their current standard of care therapy.
Participants have a 50% chance of being assigned the study medication. Neither the participants nor the study staff will know whether the study medication or placebo is received during the blinded dosing period.
When participants enter the open-label extension period, they will all receive the study medication.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like ORIGIN 3.