A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Status:
Completed
Trial end date:
2016-10-27
Target enrollment:
Participant gender:
Summary
AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed
potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism
of actions of AC-201 include the inhibition of the production and activity of caspase-1 and
interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in kidney. The
goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate
solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering
therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key
role in mediating this inflammatory response. The study is designed to test the
urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period,
followed by addition of an ULT to test the efficacy and safety of the combination and
prophylaxis of gout flares during ULT.