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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Allopurinol

Criteria

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.