Actively Recruiting
The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-07
340
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
SHR4640 tablets is a highly selective and potent URAT1 inhibitors. The study is being conducted to evaluate the efficacy, and safety of SHR4640 tablet combined with 40 mg/d febuxostat tablet in reducing uric acid in subjects with primary gout and hyperuricemia The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and 40 mg/d febuxostat compared with 60 mg/d febuxostat in primary gout and hyperuricemia subjects with inadequate control on 40 mg/d febuxostat for 12 weeks.
CONDITIONS
Official Title
The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to follow the study protocol
- Aged 18 to 75 years, male or female
- Receiving febuxostat 40 mg/day stably for at least 6 weeks before randomization
- Fasting serum uric acid 290 bmol/L at first measurement and 360 bmol/L after stable febuxostat for at least 2 weeks during screening
- Meet gout classification criteria by ACR 1977 or ACR/EULAR 2015
- Body Mass Index between 18 and 35 kg/m2
You will not qualify if you...
- Pregnant or lactating women
- Females of childbearing potential or males not using effective contraception from screening to last dose
- Average daily alcohol intake above 14 g for females or 28 g for males within 1 month before screening
- Drug abuse history
- Poor compliance affecting safety/efficacy assessment
- Laboratory abnormalities: ALT, AST, or bilirubin > 2 times upper limit; eGFR < 60 mL/(minx1.73m2); HbA1c 5%; positive hepatitis B, C, HIV, or syphilis tests; low blood counts; prolonged QTcF > 450 ms
- Hypersensitivity to study drugs or components; intolerance or contraindication to febuxostat or citrate
- Secondary hyperuricemia from other causes
- Other joint diseases that may confuse gout diagnosis
- Suspected or confirmed urinary stones within 4 weeks before randomization
- Gout flare within 2 weeks before randomization
- Active or recent peptic ulcer
- History of xanthinuria
- Malignant tumors within 5 years except certain skin and cervical conditions
- Recent or recurrent infections or severe infections requiring hospitalization or IV antibiotics
- Use of systemic immunosuppressants
- Moderate to severe heart failure
- Major cardiovascular/cerebrovascular events within 1 year
- Poorly controlled hypertension
- Severe or uncontrolled diseases
- Major surgery within 3 months or planned
- Recent large blood loss or transfusion
- Participation in other clinical trials or use of investigational drugs/devices within specified timeframes
- Use of other urate-lowering drugs or drugs interacting with febuxostat within specified timeframes
- Use of certain medications with unstable doses within 2 weeks before randomization
AI-Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
H
Haoshu Cui
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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