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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052932
• Other study ID #: SHR4640-301
• Status: Completed
• Phase: Phase 3
• Start date: July 16, 2019
• Est. completion date: July 14, 2021

Study information

• Verified date: June 2022
• 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 placebo and Allopurinol in patients with gout

Recruitment information / eligibility

• Status: Completed
• Enrollment: 594
• Est. completion date: July 14, 2021
• Est. primary completion date: July 14, 2021
• 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 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.

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• SHR4640 dose1
tablets,dose1,QD
• SHR4640 dose2
tablets,dose2,QD
• Placebo oral tablet
tablets,QD
• Allopurinol 300 MG
tablets,300mg,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 level=360µmol/l.	Proportion of subjects with a serum uric level=360µmol/l.	Week 12
Secondary	Proportion of subjects with a serum uric level=360µmol/l	Proportion of subjects with a serum uric level=360µmol/l	Week 36
Secondary	Percentage change from baseline in serum uric level	Percentage change from baseline in serum uric level	Up to 36 weeks
Secondary	Actual change from baseline in serum uric level	Actual change from baseline in serum uric level	Up to 36 weeks
Secondary	Proportion of subjects with a serum uric level=360µmol/l	Proportion of subjects with a serum uric level=360µmol/l	Up to 36 weeks