GoutPhase 2NCT05665699
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout
A Phase 2 study testing D-0120 and Allopurinol in people with Gout, run by InventisBio Co., Ltd at 19 sites in United States.
Trial summary
D-0120 is being tested in combination with Allopurinol in adult subjects with Gout. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout
- What is being tested?
- D-0120 and Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 19 sitesUnited States
- Study dates
- 17 Apr 2023to 30 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response
- Subject has had at least 2 gout flares in the previous 12 months.
- Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive).
- Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug.
- Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator
Who cannot join
- Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
- Women who are pregnant or breastfeeding
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Site Center
Bellevue, Washington, 98004
Study Center
Birmingham, Alabama, 35233
Study Center
Bristol, Tennessee, 37620
Study Center
Brownsburg, Indiana, 46254
Study Center
Evergreen Park, Illinois, 60805
Site Center
Fort Worth, Texas, 76109
Site Center
Hendersonville, Tennessee, 37075
Study Center
Hickory, North Carolina, 28601
Study Center
Knoxville, Tennessee, 37909
Site Center
Louisville, Kentucky, 40205
Study Center
Morgantown, West Virginia, 26505
Site Center
Plantation, Florida, 33324
Site Center
Richmond, Virginia, 23219
Study Center
Rocky Mount, North Carolina, 27804
Study Center
Salisbury, North Carolina, 28144
Study Center
Scottdale, Pennsylvania, 15683
Site Center
The Woodlands, Texas, 77382
Study Center
Wilmington, North Carolina, 28401
Study Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Open-Label, Multiple-Dose Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout
D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.
- Conditions
- Gout
- Being tested
- D-0120, Allopurinol
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0120Drug
increasing dose of D-0120
AllopurinolDrug
standard dosing
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol Receives: Drug: D-0120; Drug: Allopurinol |
| Cohort B | Experimental | week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol Receives: Drug: D-0120; Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start17 Apr 2023
- Primary completion31 Jul 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies 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
- Model description
- Randomized , Open Label, Multiple Dose
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathryn Stazzone, Study director, InventisBio Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665699
- Sponsor's protocol ID
- D0120-205
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multiple-Dose Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout
- ClinicalTrials.gov ID
- NCT05665699
- Acronym / sponsor ID
- D0120-205
- Conditions
- Gout
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 27 Dec 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.
D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized , Open Label, Multiple Dose
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: D-0120, Drug: Allopurinolweek 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol |
| Cohort B | Experimental | Drug: D-0120, Drug: Allopurinolweek 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response
- Subject has had at least 2 gout flares in the previous 12 months.
- Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive).
- Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug.
- Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator
Key exclusion criteria (2 listed)
- Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
- Women who are pregnant or breastfeeding
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-0120increasing dose of D-0120 | Drug | Cohort A, Cohort B |
| Allopurinolstandard dosing | Drug | Cohort A, Cohort B |
Primary outcome
• To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12
Time frame: 12 weeks
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 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Kathryn Stazzone study director
InventisBio Co., Ltd
19 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 Allopurinol in people with Gout, run by InventisBio Co., Ltd at 19 sites in United States.
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 5 inclusion and 2 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
• To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12 (time frame: 12 weeks). 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 9 Jul 2026.