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

Sponsor

InventisBio Co., Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05504083

Collaborator

(none)

Enrollment

Locations

Arms

21.2

Anticipated Duration (Months)

3.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia	Drug: D-0120 Drug: Benzbromarone	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: D-0120 group 1

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

Drug: D-0120

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 2

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

Drug: D-0120

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.

Active Comparator: Benzbromarone

take benzbromarone orally during the treatment period.

Drug: Benzbromarone

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.

Outcome Measures

Primary Outcome Measures

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

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;
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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:

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.

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	Country
1	Inner Mongolia Baogang Hospital	Baotou	China
2	Beijing Chao-yang Hospital, Capital Medical University	Beijing	China
3	Peking Union Medical College Hospital	Beijing	China
4	The First Hospital of Jilin University	Changchun	China
5	The First People's Hospital of Changzhou	Changzhou	China
6	Foshan Nanhai People's Hospital	Foshan	China
7	Guangzhou First People's Hospital	Guangzhou	China
8	Nanfang Hospital	Guangzhou	China
9	The Second People's Hospital of Guangdong Province	Guangzhou	China
10	Zhujiang Hospital of Southern Medical University	Guangzhou	China
11	The First Affiliated Hospital of Hainan Medical College	Haikou	China
12	The First Affiliated Hospital Of University Of South China	Hengyang	China
13	Huzhou Third People's Hospital	Huzhou	China
14	First Affiliated Hospital of Kunming Medical University	Kunming	China
15	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	China
16	Affiliated Hospital of North Sichuan Medical College	Nanchong	China
17	Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University	Nanjing	China
18	Zhongda Hospital Southeast University	Nanjing	China
19	Affiliated Hospital of Nantong University	Nantong	China
20	Ningbo Huamei Hospital, University of Chinese Academy of Sciences	Ningbo	China
21	Changhai Hospital of Shanghai	Shanghai	China
22	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	China
23	Qinghai Province People's Hospital	Xining	China
24	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	China
25	Zigong Fourth People's Hospital	Zigong	China

Sponsors and Collaborators

InventisBio Co., Ltd

Investigators

Principal Investigator: Xiaofeng Zeng, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

InventisBio Co., Ltd

ClinicalTrials.gov Identifier:

NCT05504083

Other Study ID Numbers:

D0120-206

First Posted:

Aug 17, 2022

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperuricemia

Benzbromarone

Study Results

No Results Posted as of Aug 17, 2022