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

Phase 3

Completed

• Conditions: Gout
• Interventions: Drug: SHR4640; Drug: Allopurinol

• Registration Number: NCT04956432
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-09
• Primary Completion: 2023-12-13
• Study Completion: 2024-08-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 779

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR4640	SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks
Treatment group B	Allopurinol	Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (1)

RenJi Hospital, Shanghai JiaoTong University School Of Medicine; 🇨🇳 Shanghai, Shanghai, China