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

InventisBio

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: D-0120; Drug: Benzbromarone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05504083

D0120-206

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;

2. 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:

   1. 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);
   2. 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;

3. At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2;

4. Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion criteria

1. Prior intolerance to benzbromarone or contraindication to medication;
2. Secondary hyperuricemia caused by tumor, chronic kidney disease, blood disease or drugs, etc.;
3. Arthropathy caused by arthritis rheumatoid, purulent arthritis, traumatic arthritis, psoriatic arthritis, pseudogout or systemic lupus erythematosus, etc.;
4. Arthropathy caused by chemotherapy, radiotherapy or chronic lead poisoning;
5. Urinary calculi confirmed by B-ultrasound during screening period;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 4 patient groups

D-0120 group 1

Experimental group

Description:

take D-0120 dose 1 orally during the treatment period.

Treatment:

Drug: D-0120

D-0120 group 2

Experimental group

Description:

take D-0120 dose 2 orally during the treatment period.

Treatment:

Drug: D-0120

Benzbromarone

Active Comparator group

Description:

take benzbromarone orally during the treatment period.

Treatment:

Drug: Benzbromarone

D-0120 group 3

Experimental group

Description:

take D-0120 dose 3 orally during the treatment period.

Treatment:

Drug: D-0120