Clinical trial NCT04956432: A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 779
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Proportion of subjects with a serum uric acid level≤360 μmol/L
timeFrame: Start of Treatment to end of study (approximately 16 weeks)
Secondary outcomes:
measure: Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment
timeFrame: Start of Treatment to end of study (approximately 16 weeks)
measure: Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment
timeFrame: Start of Treatment to end of study (approximately 16 weeks)
measure: The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment
timeFrame: Start of Treatment to end of study (approximately 16 weeks)
measure: Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment
timeFrame: Start of Treatment to end of study (approximately 52 weeks)
measure: change value of serum uric acid from baseline at each visit within 52 weeks of treatment
timeFrame: Start of Treatment to end of study (approximately 52 weeks)
measure: proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment
timeFrame: Start of Treatment to end of study (approximately 52 weeks)
measure: serum uric acid value at each visit within 52 weeks of treatment
timeFrame: Start of Treatment to end of study (approximately 52 weeks)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital, Shanghai JiaoTong University School Of Medicine
state: Shanghai
Study officials:
References: