GoutPhase 3NCT04956432
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
A Phase 3 study testing SHR4640 and Allopurinol in people with Gout, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in 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?
- SHR4640 and Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 779 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2021to 23 Aug 2024
- Phase
- Phase 3
- 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
- Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2.
Who cannot join
- Subject who is pregnant or breastfeeding;
- Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
- Subject with a positive test for HLA-B*5801;
- Estimated glomerular filtration rate (MDRD formula) <60ml/min;
- HbA1c≥8%;
- Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640;
Show all 11Show fewer
- Subject with kidney stones or suspicion of kidney stones;
- Subject who has acute gout flares within 2 weeks before randomization;
- Subject with a history of malignancy within the previous 5 years;
- Subject with a history of active peptic ulcer within a year;
- Subject with a history of xanthine urine.
Trial locations and contacts
1 site in 1 country.
China1 site
RenJi Hospital, Shanghai JiaoTong University School Of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.
- Conditions
- Gout
- Being tested
- SHR4640, Allopurinol
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640Drug
SHR4640 Dose 1 ,tablets, QD
AllopurinolDrug
Allopurinol 300mg, tablets, QD
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks Receives: Drug: SHR4640 |
| Treatment group B | Active comparator | Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks. Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a serum uric acid level≤360 μmol/L
Measured: Start of Treatment to end of study (approximately 16 weeks)
Secondary outcomes (7)
Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment
Measured: Start of Treatment to end of study (approximately 16 weeks)
Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment
Measured: Start of Treatment to end of study (approximately 16 weeks)
The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment
Measured: Start of Treatment to end of study (approximately 16 weeks)
Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment
Measured: Start of Treatment to end of study (approximately 52 weeks)
change value of serum uric acid from baseline at each visit within 52 weeks of treatment
Measured: Start of Treatment to end of study (approximately 52 weeks)
proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment
Measured: Start of Treatment to end of study (approximately 52 weeks)
serum uric acid value at each visit within 52 weeks of treatment
Measured: Start of Treatment to end of study (approximately 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start15 Jun 2021
- Primary completion13 Dec 2023
- Study completion23 Aug 2024
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 Jiangsu HengRui Medicine Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956432
- Sponsor's protocol ID
- SHR4640-303
- Status last verified
- Jan 2025
- First submitted
- 7 Jul 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
- ClinicalTrials.gov ID
- NCT04956432
- Acronym / sponsor ID
- SHR4640-303
- Conditions
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 9 Jul 2021 (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 study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR4640SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks |
| Treatment group B | Active comparator | Drug: AllopurinolAllopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2.
Key exclusion criteria (11 listed)
- Subject who is pregnant or breastfeeding;
- Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
- Subject with a positive test for HLA-B*5801;
- Estimated glomerular filtration rate (MDRD formula) <60ml/min;
- HbA1c≥8%;
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 |
|---|---|---|
| SHR4640SHR4640 Dose 1 ,tablets, QD | Drug | Treatment group A |
| AllopurinolAllopurinol 300mg, tablets, QD | Drug | Treatment group B |
Primary outcome
Proportion of subjects with a serum uric acid level≤360 μmol/L
Time frame: Start of Treatment to end of study (approximately 16 weeks)
7 secondary outcomes
Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment
Time frame: Start of Treatment to end of study (approximately 16 weeks)
The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment
Time frame: Start of Treatment to end of study (approximately 52 weeks)
change value of serum uric acid from baseline at each visit within 52 weeks of treatment
Time frame: Start of Treatment to end of study (approximately 52 weeks)
proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment
Time frame: Start of Treatment to end of study (approximately 52 weeks)
serum uric acid value at each visit within 52 weeks of treatment
Time frame: Start of Treatment to end of study (approximately 52 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 24 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR4640 and Allopurinol in people with Gout, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 1 inclusion and 11 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of subjects with a serum uric acid level≤360 μmol/L (time frame: Start of Treatment to end of study (approximately 16 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 24 Jan 2025.