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NCT Number: NCT04052932

A Study of Evaluating 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 placebo and Allopurinol in patients 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, 200000, 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;
  • 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 allopurinal, 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 dose1

Drug

tablets，dose1，QD

SHR4640 dose2

Drug

tablets，dose2，QD

Placebo oral tablet

Drug

tablets，QD

Allopurinol 300 MG

Drug

tablets，300mg，QD

Primary outcomes

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

    Time frame: Week 12

    Proportion of subjects with a serum uric level≤360μmol/l.

Secondary outcomes

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

    Time frame: Week 36

    Proportion of subjects with a serum uric level≤360μmol/l

  2. Percentage change from baseline in serum uric level

    Time frame: Up to 36 weeks

    Percentage change from baseline in serum uric level

  3. Actual change from baseline in serum uric level

    Time frame: Up to 36 weeks

    Actual change from baseline in serum uric level

  4. Proportion of subjects with a serum uric level≤360μmol/l

    Time frame: Up to 36 weeks

    Proportion of subjects with a serum uric level≤360μmol/l

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2019
Registry last updated
Jun 13, 2022

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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