HyperuricemiaPhase 2NCT05504083
Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients
A Phase 2 study testing D-0120 and Benzbromarone in people with Hyperuricemia, run by InventisBio Co., Ltd at 24 sites in China.
Trial summary
This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- D-0120 and Benzbromarone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 24 sitesChina
- Study dates
- 28 Sep 2022to 18 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Inner Mongolia Baogang Hospital
Baotou
Beijing Chao-yang Hospital, Capital Medical University
Beijing
Peking Union Medical College Hospital
Beijing
The First Hospital of Jilin University
Changchun
The First People's Hospital of Changzhou
Changzhou
Foshan Nanhai People's Hospital
Foshan
Guangzhou First People's Hospital
Guangzhou
Nanfang Hospital
Guangzhou
The Second People's Hospital of Guangdong Province
Guangzhou
Zhujiang Hospital of Southern Medical University
Guangzhou
The First Affiliated Hospital Of University Of South China
Hengyang
Huzhou Third People's Hospital
Huzhou
First Affiliated Hospital of Kunming Medical University
Kunming
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
Affiliated Hospital of North Sichuan Medical College
Nanchong
Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University
Nanjing
Zhongda Hospital Southeast University
Nanjing
Affiliated Hospital of Nantong University
Nantong
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo
Changhai Hospital of Shanghai
Shanghai
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Qinghai Province People's Hospital
Xining
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zigong Fourth People's Hospital
Zigong
About this study
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
This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout.
- Conditions
- Hyperuricemia
- Being tested
- D-0120, Benzbromarone
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0120Drug
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.
BenzbromaroneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| D-0120 group 1 | Experimental | take D-0120 dose 1 orally during the treatment period. Receives: Drug: D-0120 |
| D-0120 group 2 | Experimental | take D-0120 dose 2 orally during the treatment period. Receives: Drug: D-0120 |
| Benzbromarone | Active comparator | take benzbromarone orally during the treatment period. Receives: Drug: Benzbromarone |
| D-0120 group 3 | Experimental | take D-0120 dose 3 orally during the treatment period. Receives: Drug: D-0120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 - Day 85
Secondary outcomes (3)
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;
Measured: 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;
Measured: 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.
Measured: Day 1 - Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start28 Sep 2022
- Primary completion18 May 2024
- Study completion18 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaofeng Zeng, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504083
- Sponsor's protocol ID
- D0120-206
- Status last verified
- Oct 2024
- First submitted
- 11 Aug 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05504083
- Acronym / sponsor ID
- D0120-206
- Conditions
- Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D-0120 group 1 | Experimental | Drug: D-0120take D-0120 dose 1 orally during the treatment period. |
| D-0120 group 2 | Experimental | Drug: D-0120take D-0120 dose 2 orally during the treatment period. |
| Benzbromarone | Active comparator | Drug: Benzbromaronetake benzbromarone orally during the treatment period. |
| D-0120 group 3 | Experimental | Drug: D-0120take D-0120 dose 3 orally during the treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2;
- Hematology, Blood chemistry and Urinalysis examination were basically normal.
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-0120Part 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. | Drug | D-0120 group 1, D-0120 group 2, D-0120 group 3 |
| BenzbromaronePart 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. | Drug | Benzbromarone |
Primary outcome
Percentage of subjects with serum uric acid ≤ 360 μmol/L
Time frame: 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.
3 secondary outcomes
Percentage of subjects with serum uric acid≤ 360 μmol/L
Time frame: Day 1 -Day 56
Changes in serum uric acid
Time frame: Day 1 - Day 85
Change percentage in serum uric acid
Time frame: Day 1 - Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofeng Zeng principal investigator
Peking Union Medical College Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-0120 and Benzbromarone in people with Hyperuricemia, run by InventisBio Co., Ltd at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with serum uric acid ≤ 360 μmol/L (time frame: Day 1 - Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.