NCT07498647

Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia

A Multicenter, Randomized, Double-blind, Non-benzylisoxazole Propionic Acid (BIPA) Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of BR2251 Tablets in Patients With Primary Gout and Hyperuricemia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: BioRay Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in subjects with primary gout and hyperuricemia. This study is a dose exploration study, including a screening period (up to 2 weeks), a double-blind treatment period (12 weeks), and a follow-up period (2 weeks). The screened subjects were stratified based on whether their serum uric acid (sUA) was less than 480 μmol/L or greater than or equal to 480 μmol/L. They were randomly assigned to 4 treatment groups in a 1:1:1:1 ratio: the test drug group 1 (low-dose group), the test drug group 2 (medium-dose group), the test drug group 3 (high-dose group), and the control group (non-befloxacin tablets 40 mg), with 40 subjects in each group. Each group will use titration dosing.

Conditions

• Gout and Hyperuricemia

Interventions

Type	Name	Description
DRUG	BR2251	BR2251 low dose, mid dose, high dose, Titration regimen and Take orally once a day
DRUG	Febuxostat	Febuxostat(40mg) Titration regimen and Take orally once a day

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2026-11-30
• First posted: 2026-03-27
• Last updated: 2026-03-27