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Completed

NCT Number: NCT04956432

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

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

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RenJi Hospital, Shanghai JiaoTong University School Of Medicine

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR4640

Drug

SHR4640 Dose 1 ,tablets, QD

Allopurinol

Drug

Allopurinol 300mg, tablets, QD

Primary outcomes

  1. Proportion of subjects with a serum uric acid level≤360 μmol/L

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

Secondary outcomes

  1. Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

  2. Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

  3. The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

  4. Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment

    Time frame: Start of Treatment to end of study (approximately 52 weeks)

  5. change value of serum uric acid from baseline at each visit within 52 weeks of treatment

    Time frame: Start of Treatment to end of study (approximately 52 weeks)

  6. proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment

    Time frame: Start of Treatment to end of study (approximately 52 weeks)

  7. serum uric acid value at each visit within 52 weeks of treatment

    Time frame: Start of Treatment to end of study (approximately 52 weeks)

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 9, 2021
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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