Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients

Study Overview
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Brief Summary
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This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout.

Official Title
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A Multicenter Randomized and Controlled Phase IIb Study to Evaluate the Efficacy and Safety of D-0120 Tablets in Patients With Primary Hyperuricemia

Conditions
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Hyperuricemia

Intervention / Treatment
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* Drug: D-0120
* Drug: Benzbromarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol; Subject who meets one of the following criteria: i. History of gout attack: Meeting 2015 ACR/EULAR Gout Classification Criteria and fasting serum uric acid ≥ 480 μmol/L at screening (local laboratory of study site) ii. For asymptomatic hyperuricemia, it is acceptable to meet either of the two criteria: Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 540 μmol/L (local laboratory of study site); Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 480 μmol/L (local laboratory of study site), with concomitant primary hypertension or primary hyperlipidemia or type 2 diabetes mellitus, which is treated with a stable dose of antihypertensive or lipid-lowering or hypoglycemic treatment for at least 3 months; At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2; Hematology, Blood chemistry and Urinalysis examination were basically normal. Exclusion Criteria: Prior intolerance to benzbromarone or contraindication to medication; Secondary hyperuricemia caused by tumor, chronic kidney disease, blood disease or drugs, etc.; Arthropathy caused by arthritis rheumatoid, purulent arthritis, traumatic arthritis, psoriatic arthritis, pseudogout or systemic lupus erythematosus, etc.; Arthropathy caused by chemotherapy, radiotherapy or chronic lead poisoning; Urinary calculi confirmed by B-ultrasound during screening period;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-0120 group 1<br>take D-0120 dose 1 orally during the treatment period. | Drug: D-0120<br>* Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.<br>|
| Experimental: D-0120 group 2<br>take D-0120 dose 2 orally during the treatment period. | Drug: D-0120<br>* Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.<br>|
| Active Comparator: Benzbromarone<br>take benzbromarone orally during the treatment period. | Drug: Benzbromarone<br>* Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group.<br>|
| Experimental: D-0120 group 3<br>take D-0120 dose 3 orally during the treatment period. | Drug: D-0120<br>* Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with serum uric acid ≤ 360 μmol/L | Percentage of subjects with serum uric acid ≤ 360 μmol/L at week 12 of treatment - based on test results by the central lab. | Day 1 - Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with serum uric acid≤ 360 μmol/L | Percentage of subjects with serum uric acid ≤ 360 μmol/L at weeks 4 and 8 of treatment - based on test results by the central lab; | Day 1 -Day 56 | 
| Changes in serum uric acid | Changes in serum uric acid from baseline at weeks 4, 8 and 12 of treatment - based on test results by the central lab; | Day 1 - Day 85 | 
| Change percentage in serum uric acid | Change percentage in serum uric acid from baseline at weeks 4, 8 and 12 of treatment - based on test results by the central lab. | Day 1 - Day 85 |