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

NCT05504083 | Completed Phase 2 FDA Drug

• 1 other identifier: D0120-206
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of subjects with serum uric acid≤ 360 μmol/L

  Day 1 -Day 56

• Changes in serum uric acid

  Day 1 - Day 85

• Change percentage in serum uric acid

  Day 1 - Day 85

Study Arms (4)

D-0120 group 1

EXPERIMENTAL

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

Drug: D-0120

D-0120 group 2

EXPERIMENTAL

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

Drug: D-0120

Benzbromarone

ACTIVE COMPARATOR

take benzbromarone orally during the treatment period.

Drug: Benzbromarone

D-0120 group 3

EXPERIMENTAL

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

Drug: D-0120

Interventions

D-0120 DRUG

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.

D-0120 group 1; D-0120 group 2; D-0120 group 3

Benzbromarone DRUG

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.

Benzbromarone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (24)

Inner Mongolia Baogang Hospital

Baotou, China

Location

Beijing Chao-yang Hospital, Capital Medical University

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

The First Hospital of Jilin University

Changchun, China

Location

The First People's Hospital of Changzhou

Changzhou, China

Location

Foshan Nanhai People's Hospital

Foshan, China

Location

Guangzhou First People's Hospital

Guangzhou, China

Location

Nanfang Hospital

Guangzhou, China

Location

The Second People's Hospital of Guangdong Province

Guangzhou, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, China

Location

The First Affiliated Hospital Of University Of South China

Hengyang, China

Location

Huzhou Third People's Hospital

Huzhou, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Location

Affiliated Hospital of North Sichuan Medical College

Nanchong, China

Location

Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University

Nanjing, China

Location

Zhongda Hospital Southeast University

Nanjing, China

Location

Affiliated Hospital of Nantong University

Nantong, China

Location

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, China

Location

Changhai Hospital of Shanghai

Shanghai, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

Qinghai Province People's Hospital

Xining, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Zigong Fourth People's Hospital

Zigong, China

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

Benzbromarone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xiaofeng Zeng

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 17, 2022
• Study Start: September 28, 2022
• Primary Completion: May 18, 2024
• Study Completion: May 18, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (24)