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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04956432
• Other study ID #: SHR4640-303
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 15, 2021
• Est. completion date: July 17, 2024

Study information

• Verified date: August 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 780
• Est. completion date: July 17, 2024
• Est. primary completion date: July 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• SHR4640
SHR4640 Dose 1 ,tablets, QD
• Allopurinol
Allopurinol 300mg, tablets, QD

Locations

Country	Name	City	State
China	RenJi Hospital, Shanghai JiaoTong University School Of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with a serum uric acid level=360 µmol/L		Start of Treatment to end of study (approximately 16 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	serum uric acid value at each visit within 52 weeks of treatment		Start of Treatment to end of study (approximately 52 weeks)