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

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

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

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* Drug: SHR4640
* Drug: Allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
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; 2、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 allopurinol, 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
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) |