Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune
system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells
make proteins called antibodies, which in autoimmune disease can bind to one's own tissues
and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called
BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus
the production of antibodies. This study will assess whether treatment with atacicept can
reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not
available outside of a clinical trial, and that its potential benefits and risks have not
been fully determined.
A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a
1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept
115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.
The primary objective of the trial is to evaluate the efficacy of atacicept compared to
placebo in reducing SLE disease activity in subjects treated with standard of care (SoC)
therapy and to investigate the dose-response relationship.
The secondary objectives of the trial are:
- To evaluate the effect of atacicept in reducing corticosteroid usage
- To evaluate the safety and tolerability profile of atacicept in subjects with SLE
- To confirm the PK and PD profiles of atacicept in SLE subjects
- To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey
[SF-36].