drugset / Trial / NCT06603142

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

NCT06603142

Phase 2/3 Active not recruiting 636 enrolled Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-04-22
Primary completion
2026-04
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Subject AR882 Unknown 50 mg
Subject AR882 Unknown 75 mg
Comparator Febuxostat Small molecule 40 mg
Comparator Febuxostat 40MG Tablets Unknown

Indications