NCT06603142

Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 636 (estimated)
• Sponsor: Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia. The main questions it aims to answer are: What is the efficacy of AR882 Capsules in reducing serum uric acid levels in patients with primary gout and hyperuricemia? Researchers will compare AR882 Capsules with Febuxostat Tablets to see : Phase II: To explore the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia, aiming to determine the dosing regimen for the Phase III study Phase III: To evaluate the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia. Participants will: Be randomly assigned to receive either AR882 Capsules or Febuxostat Tablets. Undergo regular assessments of serum uric acid levels. Report any adverse events or side effects experienced during the study.

Conditions

• Primary Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Febuxostat 20MG Tablets	Febuxostat 20MG Tablets
DRUG	Febuxostat 20MG Placebo	Febuxostat 20MG Placebo
DRUG	AR882 25MG	AR882 25 MG Capsules
DRUG	AR882 12.5MG	AR882 12.5 MG Capsules
DRUG	AR882 25MG Placebo	AR882 25MG Placebo
DRUG	AR882 12.5MG Placebo	AR882 12.5MG Placebo
DRUG	Febuxostat 40MG Tablets	Febuxostat 40MG Tablets
DRUG	Febuxostat 40MG Placebo	Febuxostat 40MG Placebo

Timeline

• Start date: 2024-04-22
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China