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

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

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

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: Placebo oral tablet; Drug: SHR4640 dose1; Drug: SHR4640 dose2; Drug: Allopurinol 300 MG

• Study Type: Interventional
• Enrollment (Actual): 594
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Renji Hospital Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Chunde Bao, Shanghai Jiaotong University, School of Medicine, Renji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): July 14, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol
• Other Study ID Numbers: SHR4640-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No