Conditions: Gout
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: no

Brief summary:
The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.

Detailed description:
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 action of AC-201 includes the inhibition of the production and activity of caspase-1 and interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in the 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.

Arms:
arm 1: Placebo plus Febuxostat arm 2: AC-201 CR tablet plus Febuxostat

Interventions: intervention 1: Placebo intervention 2: AC-201 intervention 3: Febuxostat
Intervention descriptions: intervention 1: Placebo twice daily from Day 1 to Week 12 intervention 2: AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12 intervention 3: Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL

Protocol document: