Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03185793
• Collaborator: (none)
• Enrollment: 198
• Location: 1
• Arms: 5
• Actual Duration (Months): 12
• Patients Per Site Per Month: 16.5

Study Details

Study Description

Brief Summary

The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia	Drug: Placebo; Drug: SHR4640; Drug: benzbromarone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia (Asymptomatic and Gout)
• Actual Study Start Date: Jul 20, 2017
• Actual Primary Completion Date: Jul 20, 2018
• Actual Study Completion Date: Jul 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo placebo for 5 weeks	Drug: Placebo; Placebo once daily for 5 weeks
Experimental: 2.5mg SHR4640 SHR4640 for 5 weeks	Drug: SHR4640; 1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
Experimental: 5mg SHR4640 SHR4640 for 5 weeks	Drug: SHR4640; 1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
Experimental: 10mg SHR4640 SHR4640 for 5 weeks	Drug: SHR4640; 1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
Active Comparator: 50mg benzbromarone Benzbromarone for 5 weeks	Drug: benzbromarone; 25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects with a serum uric level≤360μmol/l. [Week 5]

Secondary Outcome Measures

1. Actual change from baseline in serum uric level. [Week 5]

2. Percentage change from baseline in serum uric level . [Week 5]

3. Rate of gout flares requiring treatment. [Up to week 5]

4. Incidence of gout flares requiring treatment. [Up to week 5]

5. Proportion of subjects with a serum uric level≤360μmol/l [At week1, 2, 3 and 4]

6. Proportion of subjects with a serum uric level consistent ≤360μmol/l [At week 3, 4 and 5]

7. Actual change from baseline in serum uric level [At week 1, 2, 3 and 4]

8. Percentage change from baseline in serum uric level [At week 1, 2, 3 and 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18-70 years, male or female;

2. Subject meets one of the following conditions:

1. Subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ BMI ≤32kg/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. Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;

4. HbA1c˃8%;

5. Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;

6. Subject with a history of malignancy;

7. Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen

8. Subject within the last 3months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack;

9. Subject has acute gout flares within 2 weeks before randomization;

10. Subject who is taking any other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) that is indicated within 2 weeks before randomization and can not stop during the study;

11. Subject who is taking more than 100mg once daily or unstable dosage aspirin within 2 weeks before randomization and can not stop during the study;

12. Subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangsu Hengrui Medicine Co., Ltd.	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

• Principal Investigator: Chunde Bao, shanghai Jiaotong University, School of Medicine, Renji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03185793
• Other Study ID Numbers: SHR4640-201
• First Posted: Jun 14, 2017
• Last Update Posted: Aug 7, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiangsu HengRui Medicine Co., Ltd.: SHR4640, Phase II, monotherapy, dose-finding
• Additional relevant MeSH terms: Hyperuricemia; Benzbromarone

Study Results

No Results Posted as of Aug 7, 2019