GoutPhase 3NCT04052932
A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout
A Phase 3 study testing SHR4640 dose1, SHR4640 dose2 and Allopurinol 300 MG 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 placebo and Allopurinol in patients 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 dose1, SHR4640 dose2 and Allopurinol 300 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 594 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2019to 14 Jul 2021
- 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;
- 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 allopurinal, or any component of SHR4640;
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- 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, 200000
About this study
Official title: A Phase3, Multicentre, Randomized, Double-Blind, Allopurinol and Placebo-Controlled Study to Evaluate the Efficacy and Safety of SHR4640 Monotherapy in Subjects With Gout
This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to placebo and Allopurinol in patients with gout
- Conditions
- Gout
- Being tested
- SHR4640 dose1, SHR4640 dose2, Placebo oral tablet, Allopurinol 300 MG
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640 dose1Drug
tablets，dose1，QD
SHR4640 dose2Drug
tablets，dose2，QD
Placebo oral tabletDrug
tablets，QD
Allopurinol 300 MGDrug
tablets，300mg，QD
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks Receives: Drug: Placebo oral tablet |
| SHR4640 dose1 | Experimental | SHR4640 dose1 once a day, orally, for 36 weeks Receives: Drug: SHR4640 dose1 |
| SHR4640 dose2 | Experimental | SHR4640 dose2 once a day, orally, for 36 weeks Receives: Drug: SHR4640 dose2 |
| Allopurinol | Active comparator | Allopurinol 300mg (milligram) once a day, Orally, for 36 week Receives: Drug: Allopurinol 300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a serum uric level≤360μmol/l.
Proportion of subjects with a serum uric level≤360μmol/l.
Measured: Week 12
Secondary outcomes (4)
Proportion of subjects with a serum uric level≤360μmol/l
Proportion of subjects with a serum uric level≤360μmol/l
Measured: Week 36
Percentage change from baseline in serum uric level
Percentage change from baseline in serum uric level
Measured: Up to 36 weeks
Actual change from baseline in serum uric level
Actual change from baseline in serum uric level
Measured: Up to 36 weeks
Proportion of subjects with a serum uric level≤360μmol/l
Proportion of subjects with a serum uric level≤360μmol/l
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start16 Jul 2019
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunde Bao, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052932
- Sponsor's protocol ID
- SHR4640-301
- Status last verified
- Jun 2022
- First submitted
- 6 Aug 2019
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase3, Multicentre, Randomized, Double-Blind, Allopurinol and Placebo-Controlled Study to Evaluate the Efficacy and Safety of SHR4640 Monotherapy in Subjects With Gout
- ClinicalTrials.gov ID
- NCT04052932
- Acronym / sponsor ID
- SHR4640-301
- Conditions
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 12 Aug 2019 (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 placebo and Allopurinol in patients with gout
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks |
| SHR4640 dose1 | Experimental | Drug: SHR4640 dose1SHR4640 dose1 once a day, orally, for 36 weeks |
| SHR4640 dose2 | Experimental | Drug: SHR4640 dose2SHR4640 dose2 once a day, orally, for 36 weeks |
| Allopurinol | Active comparator | Drug: Allopurinol 300 MGAllopurinol 300mg (milligram) once a day, Orally, for 36 week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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;
- 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 |
|---|---|---|
| SHR4640 dose1tablets，dose1，QD | Drug | SHR4640 dose1 |
| SHR4640 dose2tablets，dose2，QD | Drug | SHR4640 dose2 |
| Placebo oral tablettablets，QD | Drug | Placebo |
| Allopurinol 300 MGtablets，300mg，QD | Drug | Allopurinol |
Primary outcome
Proportion of subjects with a serum uric level≤360μmol/l.
Time frame: Week 12
Proportion of subjects with a serum uric level≤360μmol/l.
4 secondary outcomes
Proportion of subjects with a serum uric level≤360μmol/l
Time frame: Week 36
Percentage change from baseline in serum uric level
Time frame: Up to 36 weeks
Actual change from baseline in serum uric level
Time frame: Up to 36 weeks
Proportion of subjects with a serum uric level≤360μmol/l
Time frame: Up to 36 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 13 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Gout
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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.
Chunde Bao principal investigator
RenJi Hospital
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 dose1, SHR4640 dose2 and Allopurinol 300 MG 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 2 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 13 Jun 2022. 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. 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 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 level≤360μmol/l. (time frame: Week 12). 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 13 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.