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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04052932

Enrollment

594

Registered

2019-08-12

Start date

2019-07-16

Completion date

2021-07-14

Last updated

2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

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

Interventions

DRUGSHR4640 dose1

tablets，dose1，QD

DRUGSHR4640 dose2

tablets，dose2，QD

DRUGPlacebo oral tablet

tablets，QD

DRUGAllopurinol 300 MG

tablets，300mg，QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of subjects with a serum uric level≤360μmol/l.	Week 12	Proportion of subjects with a serum uric level≤360μmol/l.

Secondary

Measure	Time frame	Description
Proportion of subjects with a serum uric level≤360μmol/l	Week 36	Proportion of subjects with a serum uric level≤360μmol/l
Percentage change from baseline in serum uric level	Up to 36 weeks	Percentage change from baseline in serum uric level
Actual change from baseline in serum uric level	Up to 36 weeks	Actual change from baseline in serum uric level

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026