Primary Gout and HyperuricemiaPhase 2NCT05513976
Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
A Phase 2 study testing SHR4640 tablet and febuxostat tablet in people with Primary Gout and Hyperuricemia, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
SHR4640 tablets is a highly selective and potent URAT1 inhibitors,study number is SHR4640-203. The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and febuxostat compared with placebo and febuxostat in primary gout and hyperuricemia subjects with inadequate control on… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Gout and Hyperuricemia
- What is being tested?
- SHR4640 tablet and febuxostat tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2022to 20 Sep 2023
- 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
- Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
- The screening age should be 18-65 years old (including both ends), male or female; 3. Receiving febuxostat dose ≥40mg/ day, not more than 80mg/ day, stable dose for ≥6 weeks, fasting serum uric acid ≥390µmol/L at screening; 4. Meet the 1977 or 2015 American College of Rheumatology (ACR) criteria for classification of gout; 5、18kg/m2≤ Body weight Mass index (BMI) ≤35kg/m2.
Who cannot join
- General Situation:
- 1) Pregnant or lactating women;
- 2) Refusal or use of medically unapproved contraceptive measures by fertile women or men (except for non-fertile partners) within 3 months of screening to the last medication for men and 6 months for women;
- 3) The average daily alcohol intake in the 1 month prior to screening was more than 14g (e.g., 145mL wine, 497mL beer, or 43mL low-alcohol liquor) for women and more than 28g (e.g., 290mL wine, 994mL beer, or 86mL low-alcohol liquor) for men;
- 4) Drug abusers;
- 5) Subjects whose compliance is considered by the investigator to be poor and affect the evaluation of the safety and efficacy of the trial drug.
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- The following conditions occurred in the laboratory examination within 3 weeks before randomization:
- 1) upper limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (T-Bil);
- 2) Serum creatinine was calculated using simplified Diet adjustment for Kidney Disease (MDRD) formula and eGFR was less than 45mL/ (min×1.73m2).
- 3) Glycosylated hemoglobin (HbA1c) ≥8%;
- 4) Having active hepatitis B [hepatitis B surface antigen (HBsAg) positive and HBV deoxyribonucleic acid (HBV-DNA) ≥500 IU/mL or 2500 copies/mL], or anti-hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, Or a positive syphilis antibody test;
- 5) White blood cell < 3.0×109/L, and/or hemoglobin < 90 g/L, and/or platelet < 80×109/L.
- Any of the following medical history or comorbidities:
- 1) Allergy, allergy to SHR4640 or any component of SHR4640, or previous intolerance to febuxostat or contraindications;
- 2) Secondary hyperuricemia caused by tumors, chronic kidney diseases, blood diseases, drugs and other reasons;
- 3) There are other joint lesions that researchers believe may confuse gouty arthritis, such as rheumatoid arthritis, pyogenic arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, systemic lupus erythematosus, or joint lesions caused by chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive nephropathy, etc.
- 4) Urinary calculi were detected or suspected by B-ultrasound within 3 weeks before randomization;
- 5) Gout attack within 2 weeks before randomization;
- 6) History of active peptic ulcer within 1 year before screening or active peptic ulcer at screening;
- 7) History of xanthine urine;
- 8) The presence of malignancy, or a history of malignancy within 5 years prior to screening (except for treated non-melanoma of the skin without signs of recurrence, and resected cervical intraepithelial neoplasia);
- 9) History of chronic infection or recurrent infection within 1 year before screening; Or a serious infection (including but not limited to hepatitis, sepsis, pneumonia, pyelonephritis, etc.) or infection leading to hospitalization in the 3 months prior to screening; Or an infection that was treated with intravenous antibiotics before screening; Or open draining wounds or ulcers at the time of screening;
- 10) Patients who need to use immunosuppressive agents for systemic therapy;
- 11) Moderate to severe congestive heart failure (New York Heart Association class III or IV);
- 12) Myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, brain infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack, and other cardiovascular and cerebrovascular events leading to hospitalization occurred within 1 year before screening;
- 13) Poorly controlled hypertension [systolic blood pressure (SBP) ≥180mmHg and/or diastolic blood pressure (DBP) ≥110mmHg at rest, reconfirmed];
- 14) combined with other serious or poorly controlled diseases;
- 15) Patients who had undergone major surgery within 3 months prior to surgery, or had not recovered from surgery, or planned to undergo major surgery during the study period;
- 16) Blood donation (or blood loss) and blood donation (or blood loss) ≥400 mL within 3 months before screening, or receiving blood transfusion.
- Use any of the following drugs or participate in clinical trials:
- 1) Participated in any investigational drug (including investigational vaccine) clinical trial and used investigational drug within 3 months before screening or within the half-life of 5 investigational drugs (whichever is longer);
- 2) Participated in any clinical trial of medical device within 3 months prior to screening (excluding failed screening subjects);
- 3) Use other uric acid lowering drugs (allopurinol, benzbromarone, and recombinant uricase) within 6 weeks before screening;
- 4) Drugs that interact with febuxostat (theophylline, azathioprine, mercaptopurine) were used within 6 weeks before screening;
- 5) Within 6 weeks before screening, the daily dose of aspirin was more than 100mg or the dose was unstable;
- 6) Use any diuretic within 2 weeks before randomization;
- 7) Blood pressure, lipid-lowering and glucose-lowering drugs with unstable dose were used within 2 weeks before randomization.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia Subjects With Inadequate Control on Febuxostat
SHR4640 tablets is a highly selective and potent URAT1 inhibitors,study number is SHR4640-203. The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and febuxostat compared with placebo and febuxostat in primary gout and hyperuricemia subjects with inadequate control on febuxostat for 12 weeks.
- Conditions
- Primary Gout and Hyperuricemia
- Being tested
- SHR4640 tablet, febuxostat tablet, SHR4640 placebo tablet
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640 tabletDrug
SHR4640 tablet 5mg
SHR4640 tabletDrug
SHR4640 tablet 10mg
febuxostat tabletDrug
febuxostat tablet 40mg or 60mg or 80mg based on prior medication
SHR4640 placebo tabletDrug
SHR4640 placebo tablet 5 or 10mg
| Study group | Role | What they receive |
|---|---|---|
| treatment group A | Experimental | Not described Receives: Drug: SHR4640 tablet; Drug: febuxostat tablet |
| treatment group B | Experimental | Not described Receives: Drug: SHR4640 tablet; Drug: febuxostat tablet |
| treatment group C | Placebo comparator | Not described Receives: Drug: febuxostat tablet; Drug: SHR4640 placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with serum uric acid ≤360μmol/L
Measured: After 12 weeks of treatment
Secondary outcomes (5)
Proportion of subjects with serum uric acid ≤ 300μmol/L (response)
Measured: After 12 weeks of treatment
Proportion of subjects with serum uric acid ≤360μmol/L at the last two tests at 12 weeks of double-blind treatment
Measured: After 12 weeks of treatment
Percentage change in serum uric acid from baseline at each visit
Measured: within 12 weeks of double-blind treatment
Changes in serum uric acid from baseline at each visit
Measured: within 12 weeks of double-blind treatment
Proportion of subjects with serum uric acid ≤360μmol/L at each visit
Measured: within 12 weeks of double-blind treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start15 Sep 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Gout and HyperuricemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR4640 VS. Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (estimated)
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
- NCT05513976
- Sponsor's protocol ID
- SHR4640-203
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 24 Aug 2022
- 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 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia Subjects With Inadequate Control on Febuxostat
- ClinicalTrials.gov ID
- NCT05513976
- Acronym / sponsor ID
- SHR4640-203
- Conditions
- Primary Gout and Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 24 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.
SHR4640 tablets is a highly selective and potent URAT1 inhibitors,study number is SHR4640-203. The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and febuxostat compared with placebo and febuxostat in primary gout and hyperuricemia subjects with inadequate control on febuxostat for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- SHR4640 VS. Placebo
| Arm | Type | Receives |
|---|---|---|
| treatment group A | Experimental | Drug: SHR4640 tablet, Drug: febuxostat tablet |
| treatment group B | Experimental | Drug: SHR4640 tablet, Drug: febuxostat tablet |
| treatment group C | Placebo comparator | Drug: febuxostat tablet, Drug: SHR4640 placebo tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
- The screening age should be 18-65 years old (including both ends), male or female; 3. Receiving febuxostat dose ≥40mg/ day, not more than 80mg/ day, stable dose for ≥6 weeks, fasting serum uric acid ≥390µmol/L at screening; 4. Meet the 1977 or 2015 American College of Rheumatology (ACR) criteria for classification of gout; 5、18kg/m2≤ Body weight Mass index (BMI) ≤35kg/m2.
Key exclusion criteria (37 listed)
- General Situation:
- The following conditions occurred in the laboratory examination within 3 weeks before randomization:
- Any of the following medical history or comorbidities:
- Use any of the following drugs or participate in clinical trials:
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 tabletSHR4640 tablet 5mg | Drug | treatment group A |
| SHR4640 tabletSHR4640 tablet 10mg | Drug | treatment group B |
| febuxostat tabletfebuxostat tablet 40mg or 60mg or 80mg based on prior medication | Drug | treatment group A, treatment group B, treatment group C |
| SHR4640 placebo tabletSHR4640 placebo tablet 5 or 10mg | Drug | treatment group C |
Primary outcome
Proportion of subjects with serum uric acid ≤360μmol/L
Time frame: After 12 weeks of treatment
5 secondary outcomes
Proportion of subjects with serum uric acid ≤ 300μmol/L (response)
Time frame: After 12 weeks of treatment
Proportion of subjects with serum uric acid ≤360μmol/L at the last two tests at 12 weeks of double-blind treatment
Time frame: After 12 weeks of treatment
Percentage change in serum uric acid from baseline at each visit
Time frame: within 12 weeks of double-blind treatment
Changes in serum uric acid from baseline at each visit
Time frame: within 12 weeks of double-blind treatment
Proportion of subjects with serum uric acid ≤360μmol/L at each visit
Time frame: within 12 weeks of double-blind treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR4640 tablet and febuxostat tablet in people with Primary Gout and Hyperuricemia, run by Jiangsu HengRui Medicine Co., Ltd..
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 37 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wangwang Zhi (+86 18036618683, Wangwang.zhi@hengrui.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with serum uric acid ≤360μmol/L (time frame: After 12 weeks of treatment). 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 Aug 2022.