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

Phase 2

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: D-0120; Drug: Benzbromarone

• Registration Number: NCT05504083
• Lead Sponsor: InventisBio Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-14
• Study First Posted: 2022-08-17
• Study Start: 2022-09-28
• Primary Completion: 2024-05-18
• Study Completion: 2024-05-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-0120 group 1	D-0120	take D-0120 dose 1 orally during the treatment period.
Benzbromarone	Benzbromarone	take benzbromarone orally during the treatment period.
D-0120 group 3	D-0120	take D-0120 dose 3 orally during the treatment period.
D-0120 group 2	D-0120	take D-0120 dose 2 orally during the treatment period.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (24)

Inner Mongolia Baogang Hospital; 🇨🇳 Baotou, China

Beijing Chao-yang Hospital, Capital Medical University; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

The First Hospital of Jilin University; 🇨🇳 Changchun, China

The First People's Hospital of Changzhou; 🇨🇳 Changzhou, China

Foshan Nanhai People's Hospital; 🇨🇳 Foshan, China

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, China

Nanfang Hospital; 🇨🇳 Guangzhou, China

The Second People's Hospital of Guangdong Province; 🇨🇳 Guangzhou, China

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, China

The First Affiliated Hospital Of University Of South China; 🇨🇳 Hengyang, China

Huzhou Third People's Hospital; 🇨🇳 Huzhou, China

First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, China

The First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, China

Affiliated Hospital of North Sichuan Medical College; 🇨🇳 Nanchong, China

Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University; 🇨🇳 Nanjing, China

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, China

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, China

Ningbo Huamei Hospital, University of Chinese Academy of Sciences; 🇨🇳 Ningbo, China

Changhai Hospital of Shanghai; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

Qinghai Province People's Hospital; 🇨🇳 Xining, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

Zigong Fourth People's Hospital; 🇨🇳 Zigong, China