NCT02287818

A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF AC-201 IN SUBJECTS WITH GOUT

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: TWi Biotechnology, Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Placebo	Placebo twice daily from Day 1 to Week 12
DRUG	AC-201	AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
DRUG	Febuxostat	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

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-10-27
• Completion: 2016-10-27
• First posted: 2014-11-11
• Last updated: 2022-06-28
• Results posted: 2020-10-28

Locations

1 site across 1 country: Taiwan