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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hyperuricemia
• Intervention / Treatment: Drug: D-0120; Drug: Benzbromarone

• Study Type: Interventional
• Enrollment (Estimated): 121
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nan Tang; Phone Number: 13581714593; Email: nancy.tang@sanofi.com

Study Locations

• China
  • Baotou, China
    • Not yet recruiting
    • Inner Mongolia Baogang Hospital
  • Beijing, China
    • Not yet recruiting
    • Peking Union Medical College Hospital
  • Beijing, China
    • Not yet recruiting
    • Beijing Chao-Yang Hospital, Capital Medical University
  • Changchun, China
    • Not yet recruiting
    • The First Hospital of Jilin University
  • Changzhou, China
    • Not yet recruiting
    • The First People's Hospital Of Changzhou
  • Foshan, China
    • Not yet recruiting
    • Foshan Nanhai People's Hospital
  • Guangzhou, China
    • Not yet recruiting
    • Zhujiang Hospital of Southern Medical University
  • Guangzhou, China
    • Not yet recruiting
    • Nanfang Hospital
  • Guangzhou, China
    • Not yet recruiting
    • Guangzhou First People's Hospital
  • Guangzhou, China
    • Not yet recruiting
    • The Second People's Hospital of Guangdong Province
  • Hengyang, China
    • Recruiting
    • The First Affiliated Hospital of University of South China
  • Huzhou, China
    • Not yet recruiting
    • Huzhou third people's Hospital
  • Kunming, China
    • Not yet recruiting
    • First Affiliated Hospital of Kunming Medical University
  • Luoyang, China
    • Not yet recruiting
    • The First Affiliated Hospital of Henan University of Science and Technology
  • Nanchong, China
    • Not yet recruiting
    • Affiliated Hospital of North Sichuan Medical College
  • Nanjing, China
    • Not yet recruiting
    • Zhongda Hospital Southeast University
  • Nanjing, China
    • Not yet recruiting
    • Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University
  • Nantong, China
    • Not yet recruiting
    • Affiliated Hospital of Nantong University
  • Ningbo, China
    • Not yet recruiting
    • Ningbo Huamei Hospital, University of Chinese Academy of Sciences
  • Shanghai, China
    • Not yet recruiting
    • Changhai Hospital of Shanghai
  • Xi'an, China
    • Not yet recruiting
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xining, China
    • Not yet recruiting
    • Qinghai Province People's Hospital
  • Zhengzhou, China
    • Not yet recruiting
    • The First Affiliated Hospital of Zhengzhou University
  • Zigong, China
    • Not yet recruiting
    • Zigong Fourth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D-0120 group 1; take D-0120 dose 1 orally during the treatment period.	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.
Experimental: D-0120 group 2; take D-0120 dose 2 orally during the treatment period.	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.
Active Comparator: Benzbromarone; take benzbromarone orally during the treatment period.	Drug: 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.
Experimental: D-0120 group 3; take D-0120 dose 3 orally during the treatment period.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd
• Investigators: Principal Investigator: Xiaofeng Zeng, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): April 5, 2024
• Study Completion (Estimated): April 26, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Antirheumatic Agents; Gout Suppressants; Uricosuric Agents; Benzbromarone
• Other Study ID Numbers: D0120-206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No