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

Hyperuricemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504083
• Other study ID #: D0120-206
• Status: Recruiting
• Phase: Phase 2
• Start date: September 28, 2022
• Est. completion date: April 26, 2024

Study information

• Verified date: April 2023
• Source: InventisBio Co., Ltd
• Contact: Nan Tang
• Phone: 13581714593
• Email: nancy.tang[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 121
• Est. completion date: April 26, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• D-0120
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.
• Benzbromarone
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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
InventisBio Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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