NCT07362355

The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia

A Multicenter, Randomized, Double-blind, Active-controlled Parallel-group Phase ii Clinical Study to Compare the Efficacy and Safety of SHR4640 Tablets Combined With Febuxostat Tablets at 40 mg/Day Versus Febuxostat Tablets With Dose Escalation in Treatment of Primary Gout and Hyperuricemia Subjects With Inadequate Control on 40 mg/Day Febuxostat

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

SHR4640 tablets is a highly selective and potent URAT1 inhibitors. The study is being conducted to evaluate the efficacy, and safety of SHR4640 tablet combined with 40 mg/d febuxostat tablet in reducing uric acid in subjects with primary gout and hyperuricemia The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and 40 mg/d febuxostat compared with 60 mg/d febuxostat in primary gout and hyperuricemia subjects with inadequate control on 40 mg/d febuxostat for 12 weeks.

Conditions

• Primary Gout and Hyperuricemia

Interventions

Type	Name	Description
DRUG	SHR4640 ；Febuxostat	SHR4640 high dose + Febuxostat
DRUG	SHR4640 ; Febuxostat	SHR4640 low dose + Febuxostat
DRUG	SHR4640	SHR4640 high dose
DRUG	SHR4640	SHR4640 low dose
DRUG	Febuxostat	Febuxostat

Timeline

• Start date: 2026-02-09
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2026-01-23
• Last updated: 2026-04-07

Locations

1 site across 1 country: China