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

NCT07362355 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR4640-204
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with serum uric acid levels of ≤360 μmol/L at week 12

  at week 12

Secondary Outcomes (8)

• Proportion of subjects with serum uric acid levels ≤300 μmol/L at week 12;

  at week 12;

• Proportion of subjects with serum uric acid levels ≤360 μmol/L at the last two test at week 12;

  at week 12;

• Proportion of subjects with serum uric acid levels ≤360 μmol/L at week 24;

  at week 24;

• Proportion of subjects with serum uric acid levels ≤300 μmol/L at week 24;

  at week 24;

• Proportion of subjects with serum uric acid levels ≤360 μmol/L at the last two test at week 24;

  at week 24;

Study Arms (5)

Treatment group A

EXPERIMENTAL

Drug: SHR4640 ；Febuxostat

Treatment group B

EXPERIMENTAL

Drug: SHR4640 ; Febuxostat

Treatment group C

EXPERIMENTAL

Drug: SHR4640

Treatment group D

EXPERIMENTAL

Drug: SHR4640

Treatment group E

ACTIVE COMPARATOR

Drug: Febuxostat

Interventions

SHR4640 DRUG

SHR4640 high dose

Treatment group C

Febuxostat DRUG

Febuxostat

Treatment group E

SHR4640 ; Febuxostat DRUG

SHR4640 low dose + Febuxostat

Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
• The screening age should be 18-75 years old (including both ends), male or female;
• Receive febuxostat at a stable dose of 40 mg/day for ≥6 weeks before randomization; have a fasting serum uric acid level ≥390 µmol/L at the first measurement, and a repeat fasting serum uric acid level ≥360 µmol/L after taking febuxostat 40 mg/day stably for ≥2 weeks during screening and run-in period,;
• Meet the gout classification criteria formulated by the American College of Rheumatology (ACR) in 1977 or the joint gout classification criteria formulated by the American College of Rheumatology and the European League Against Rheumatism (ACR/EULAR) in 2015;
• Body Mass Index (BMI) between 18 kg/m² and 35 kg/m².

You may not qualify if:

• Subjects who meet any of the following conditions will be excluded:
• \. General conditions:
• Pregnant or lactating women;
• Females of childbearing potential or males (except those whose partners are infertile) who refuse to use or use medically unapproved highly effective contraceptive measures within 6 months (for females) or 3 months (for males) from screening to the last dose of study medication;
• Average daily alcohol intake exceeding 14 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) or exceeding 28 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 1 month before screening;
• Drug abusers;
• Subjects with poor compliance judged by investigators, which may affect the safety and efficacy evaluation of the study drug.
• \. The following laboratory abnormalities within 4 weeks before randomization:
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBIL) \> 2 times the upper limit of normal (ULN);
• Estimated glomerular filtration rate (eGFR) \< 60 mL/(min×1.73m²) calculated by the Modification of Diet in Renal Disease (MDRD) formula based on serum creatinine level;
• Glycated hemoglobin (HbA1c) ≥ 8%;
• Active hepatitis B \[positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) exceeding the normal range\], or positive anti-hepatitis C virus (HCV) antibody, or positive human immunodeficiency virus (HIV) antibody, or positive syphilis antibody test;
• White blood cell count \< 3.0×10⁹/L, and/or hemoglobin \< 90 g/L, and/or platelet count \< 80×10⁹/L;
• Prolonged QTcF interval confirmed by repeated 12-lead electrocardiogram (ECG) (QTcF \> 450 ms).
• \. History of or comorbidities with any of the following:

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

ruzinurad; Febuxostat

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Haoshu Cui

CONTACT

0518-82342973; haoshu.cui.hc11@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

CN (1)