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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Gout

Treatments: Drug: SHR4640 dose2; Drug: SHR4640 dose1; Drug: Placebo oral tablet; Drug: Allopurinol 300 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT04052932

SHR4640-301

Details and patient eligibility

About

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

Enrollment: 594 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

594 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablet

SHR4640 dose1

Experimental group

Description:

SHR4640 dose1 once a day, orally, for 36 weeks

Treatment:

Drug: SHR4640 dose1

SHR4640 dose2

Experimental group

Description:

SHR4640 dose2 once a day, orally, for 36 weeks

Treatment:

Drug: SHR4640 dose2

Allopurinol

Active Comparator group

Description:

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

Treatment:

Drug: Allopurinol 300 MG