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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Gout

Treatments: Drug: Allopurinol; Drug: SHR4640

Study type: Interventional

Funder types: Industry

Identifiers

NCT04956432

SHR4640-303

Details and patient eligibility

About

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

Enrollment: 779 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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 allopurinol, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

779 participants in 2 patient groups

Treatment group A

Experimental group

Description:

SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks

Treatment:

Drug: SHR4640

Treatment group B

Active Comparator group

Description:

Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks.

Treatment:

Drug: Allopurinol