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

Study Overview
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Brief Summary
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This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to placebo and Allopurinol in patients with gout

Official Title
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A Phase3, Multicentre, Randomized, Double-Blind, Allopurinol and Placebo-Controlled Study to Evaluate the Efficacy and Safety of SHR4640 Monotherapy in Subjects With Gout

Conditions
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Gout

Intervention / Treatment
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* Drug: SHR4640 dose1
* Drug: SHR4640 dose2
* Drug: Placebo oral tablet
* Drug: Allopurinol 300 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 18 kg/m2 ≤Body mass index (BMI)≤ 35 kg/m2 Exclusion Criteria: Subject who is pregnant or breastfeeding; Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit; Subject with a positive test for HLA-B*5801; Estimated glomerular filtration rate (MDRD formula) <60ml/min; HbA1c>8%; Subject with known hypersensitivity or allergy to SHR4640 and allopurinal, or any component of SHR4640; Subject with kidney stones or suspicion of kidney stones; Subject who has acute gout flares within 2 weeks before randomization; Subject with a history of malignancy within the previous 5 years; Subject with a history of active peptic ulcer within a year; Subject with a history of xanthine urine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks | Drug: Placebo oral tablet<br>* tablets，QD<br>|
| Experimental: SHR4640 dose1<br>SHR4640 dose1 once a day, orally, for 36 weeks | Drug: SHR4640 dose1<br>* tablets，dose1，QD<br>|
| Experimental: SHR4640 dose2<br>SHR4640 dose2 once a day, orally, for 36 weeks | Drug: SHR4640 dose2<br>* tablets，dose2，QD<br>|
| Active Comparator: Allopurinol<br>Allopurinol 300mg (milligram) once a day, Orally, for 36 week | Drug: Allopurinol 300 MG<br>* tablets，300mg，QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a serum uric level≤360μmol/l. | Proportion of subjects with a serum uric level≤360μmol/l. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a serum uric level≤360μmol/l | Proportion of subjects with a serum uric level≤360μmol/l | Week 36 | 
| Percentage change from baseline in serum uric level | Percentage change from baseline in serum uric level | Up to 36 weeks | 
| Actual change from baseline in serum uric level | Actual change from baseline in serum uric level | Up to 36 weeks | 
| Proportion of subjects with a serum uric level≤360μmol/l | Proportion of subjects with a serum uric level≤360μmol/l | Up to 36 weeks |