Acute Gouty ArthritisPhase 2NCT07706777
Clinical Study of HRS-2129 for Acute Gouty Arthritis
A Phase 2 study testing HRS-2129 Tablet in people with Acute Gouty Arthritis, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for acute gouty arthritis. To explore the reasonable dosage of HRS-2129 for acute gouty arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gouty Arthritis
- What is being tested?
- HRS-2129 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 19 Aug 2026to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Subjects requiring Acute gouty arthritis
- Target joint VAS pain score ≥ 50 mm (screening)
Who cannot join
- Subjects with a history of severe allergies
- Subjects with nervous system disease
- Subjects with a history of mental illness
- Subjects with abnormal liver and renal function
- Subjects with poorly controlled hypertensive
- QTc：>450ms（male），>470ms（female）
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Yunfeng Pan
- Recruiting
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Lingyun Sun
About this study
Official title: Clinical Study on Safety and Efficacy of HRS-2129 for Acute Gouty Arthritis
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for acute gouty arthritis. To explore the reasonable dosage of HRS-2129 for acute gouty arthritis.
- Conditions
- Acute Gouty Arthritis
- Being tested
- HRS-2129 Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2129 TabletDrug
HRS-2129 Tablet; high dose
HRS-2129 TabletDrug
HRS-2129 Tablet; low dose
PlaceboDrug
HRS-2129 Tablet Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-2129 Tablet | Experimental | Not described Receives: Drug: HRS-2129 Tablet |
| Treatment group B: HRS-2129 Tablet | Experimental | Not described Receives: Drug: HRS-2129 Tablet |
| Treatment group C: HRS-2129 Tablet Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose
VAS，Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack，it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)
Measured: from ICF signing date to 24 hours after first dose
Secondary outcomes (4)
Change from baseline in VAS pain score at 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours post first dose
Measured: from ICF signing date to 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours after first dose
Time until complete disappearance of pain in the target joint
Measured: from ICF signing date to 15 days after first dose
Mean daily VAS pain score change from baseline (on-treatment)
Measured: from ICF signing date to 15 days after first dose
Safety：Incidence and severity of AE/SAE
Measured: from ICF signing date to day 14 after last dose(14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start19 Aug 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gouty ArthritisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706777
- Sponsor's protocol ID
- HRS-2129-207
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Safety and Efficacy of HRS-2129 for Acute Gouty Arthritis
- ClinicalTrials.gov ID
- NCT07706777
- Acronym / sponsor ID
- HRS-2129-207
- Conditions
- Acute Gouty Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Jul 2026 (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.
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for acute gouty arthritis. To explore the reasonable dosage of HRS-2129 for acute gouty arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-2129 Tablet | Experimental | Drug: HRS-2129 Tablet |
| Treatment group B: HRS-2129 Tablet | Experimental | Drug: HRS-2129 Tablet |
| Treatment group C: HRS-2129 Tablet Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to provide a written informed consent
- Subjects requiring Acute gouty arthritis
- Target joint VAS pain score ≥ 50 mm (screening)
Key exclusion criteria (8 listed)
- Subjects with a history of severe allergies
- Subjects with nervous system disease
- Subjects with a history of mental illness
- Subjects with abnormal liver and renal function
- Subjects with poorly controlled hypertensive
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 |
|---|---|---|
| HRS-2129 TabletHRS-2129 Tablet; high dose | Drug | Treatment group A: HRS-2129 Tablet |
| HRS-2129 TabletHRS-2129 Tablet; low dose | Drug | Treatment group B: HRS-2129 Tablet |
| PlaceboHRS-2129 Tablet Placebo | Drug | Treatment group C: HRS-2129 Tablet Placebo |
Primary outcome
Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose
Time frame: from ICF signing date to 24 hours after first dose
VAS，Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack，it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)
4 secondary outcomes
Change from baseline in VAS pain score at 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours post first dose
Time frame: from ICF signing date to 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours after first dose
Time until complete disappearance of pain in the target joint
Time frame: from ICF signing date to 15 days after first dose
Mean daily VAS pain score change from baseline (on-treatment)
Time frame: from ICF signing date to 15 days after first dose
Safety：Incidence and severity of AE/SAE
Time frame: from ICF signing date to day 14 after last dose(14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 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 HRS-2129 Tablet in people with Acute Gouty Arthritis, run by Shandong Suncadia Medicine Co., Ltd. at 2 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Tang (+0518-82342973, lei.tang.lt31@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose (time frame: from ICF signing date to 24 hours after first dose). 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 3 Sep 2026.