A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout

This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: SHR4640; Drug: Allopurinol

• Study Type: Interventional
• Enrollment (Actual): 779
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • RenJi Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2.

Exclusion Criteria:

1. Subject who is pregnant or breastfeeding;
2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
3. Subject with a positive test for HLA-B*5801;
4. Estimated glomerular filtration rate (MDRD formula) <60ml/min;
5. HbA1c≥8%;
6. Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640;
7. Subject with kidney stones or suspicion of kidney stones;
8. Subject who has acute gout flares within 2 weeks before randomization;
9. Subject with a history of malignancy within the previous 5 years;
10. Subject with a history of active peptic ulcer within a year;
11. Subject with a history of xanthine urine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks	Drug: SHR4640; SHR4640 Dose 1 ,tablets, QD
Active Comparator: Treatment group B; Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks.	Drug: Allopurinol; Allopurinol 300mg, tablets, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with a serum uric acid level≤360 μmol/L	Start of Treatment to end of study (approximately 16 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment	Start of Treatment to end of study (approximately 16 weeks)
Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment	Start of Treatment to end of study (approximately 16 weeks)
The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment	Start of Treatment to end of study (approximately 16 weeks)
Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment	Start of Treatment to end of study (approximately 52 weeks)
change value of serum uric acid from baseline at each visit within 52 weeks of treatment	Start of Treatment to end of study (approximately 52 weeks)
proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment	Start of Treatment to end of study (approximately 52 weeks)
serum uric acid value at each visit within 52 weeks of treatment	Start of Treatment to end of study (approximately 52 weeks)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): August 23, 2024

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gout Suppressants; Antirheumatic Agents; Antimetabolites; Antioxidants; Protective Agents; Free Radical Scavengers; Allopurinol
• Other Study ID Numbers: SHR4640-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No