A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout

Phase 3

Completed

• Conditions: Gout
• Interventions: Drug: SHR4640 dose1; Drug: SHR4640 dose2; Drug: Allopurinol 300 MG; Drug: Placebo oral tablet

• Registration Number: NCT04052932
• 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 placebo and Allopurinol in patients with gout

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-16
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-12
• Primary Completion: 2021-07-14
• Study Completion: 2021-07-14
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 594

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 allopurinal, 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
SHR4640 dose1	SHR4640 dose1	SHR4640 dose1 once a day, orally, for 36 weeks
SHR4640 dose2	SHR4640 dose2	SHR4640 dose2 once a day, orally, for 36 weeks
Allopurinol	Allopurinol 300 MG	Allopurinol 300mg (milligram) once a day, Orally, for 36 week
Placebo	Placebo oral tablet	Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a serum uric level≤360μmol/l.	Week 12	Proportion of subjects with a serum uric level≤360μmol/l.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a serum uric level≤360μmol/l	Up to 36 weeks	Proportion of subjects with a serum uric level≤360μmol/l
Percentage change from baseline in serum uric level	Up to 36 weeks	Percentage change from baseline in serum uric level
Actual change from baseline in serum uric level	Up to 36 weeks	Actual change from baseline in serum uric level

Trial Locations

Locations (1)

RenJi Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China