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

NCT04052932 | Completed Phase 3

• 1 other identifier: SHR4640-301
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

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

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

  Week 12

Secondary Outcomes (4)

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

  Week 36

• Percentage change from baseline in serum uric level

  Up to 36 weeks

• Actual change from baseline in serum uric level

  Up to 36 weeks

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

  Up to 36 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks

Drug: Placebo oral tablet

SHR4640 dose1

EXPERIMENTAL

SHR4640 dose1 once a day, orally, for 36 weeks

Drug: SHR4640 dose1

SHR4640 dose2

EXPERIMENTAL

SHR4640 dose2 once a day, orally, for 36 weeks

Drug: SHR4640 dose2

Allopurinol

ACTIVE COMPARATOR

Allopurinol 300mg (milligram) once a day, Orally, for 36 week

Drug: Allopurinol 300 MG

Interventions

SHR4640 dose1 DRUG

tablets，dose1，QD

SHR4640 dose1

SHR4640 dose2 DRUG

tablets，dose2，QD

SHR4640 dose2

Placebo oral tablet DRUG

tablets，QD

Placebo

Allopurinol 300 MG DRUG

tablets，300mg，QD

Allopurinol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening;
• kg/m2 ≤Body mass index (BMI)≤ 35 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

RenJi Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Gout

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chunde Bao

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 12, 2019
• Study Start: July 16, 2019
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

CN (1)