Phase 2 Gout Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have freely agreed to take part and are willing to follow all study procedures
• Adults aged 18 to 75 years old (male or female)
• People who have been taking febuxostat 40 mg per day at a steady dose for at least 6 weeks before joining, and whose blood uric acid levels remain above certain high levels during the screening period (confirm with trial site for exact measurements)
• People who have been diagnosed with gout according to recognised international medical criteria (from 1977 or 2015 guidelines)
• People with a body weight in a healthy range — specifically a Body Mass Index (BMI) between 18 and 35 kg/m²

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People of childbearing potential who are not willing or able to use an approved highly effective form of contraception during the study period (6 months for females, 3 months for males after the last dose)
• People whose regular alcohol intake exceeds certain daily limits (roughly more than one standard drink per day for women, or more than two for men, within the month before screening)
• People with a history of drug abuse
• People who the trial doctors believe are unlikely to follow the study requirements reliably
• People with certain abnormal blood test results in the 4 weeks before joining, including signs of liver stress, reduced kidney function, poorly controlled blood sugar (HbA1c of 8% or higher), active hepatitis B, hepatitis C, HIV, or syphilis, low blood cell counts, or an abnormal heart rhythm reading on an ECG
• People with a known allergy or intolerance to the study drug (SHR4640), febuxostat, or citrate
• People whose high uric acid levels are caused by another condition such as cancer, kidney disease, or blood disorders, rather than gout itself
• People who have other joint conditions that could be confused with gout, such as rheumatoid arthritis, lupus, or psoriatic arthritis
• People who had kidney stones detected on ultrasound in the 4 weeks before joining
• People who had a gout flare-up in the 2 weeks before joining
• People with a history of active stomach ulcers within the past year
• People with a rare inherited condition called xanthinuria
• People with a current or recent history (within 5 years) of cancer, with limited exceptions for certain treated skin conditions
• People with a history of ongoing or repeated infections within the past year, or serious infections requiring hospitalisation in the past 3 months, or infections treated with intravenous antibiotics in the 2 weeks before joining, or open wounds or ulcers at the time of screening
• People who need ongoing treatment with immune-suppressing medications
• People with moderate to severe heart failure
• People who had a serious heart or stroke-related event requiring hospitalisation in the year before screening (such as heart attack, stroke, or unstable chest pain)
• People with very high blood pressure that is not well controlled (confirmed by repeat measurement)
• People with other serious or poorly managed health conditions
• People who had major surgery within 3 months before screening, have not fully recovered from surgery, or are planning major surgery during the study
• People who donated or lost 400 mL or more of blood, or received a blood transfusion, within the 3 months before screening
• People who have taken part in another clinical drug trial within 3 months before screening (or within 5 half-lives of that trial drug, whichever is longer)
• People who have taken part in a medical device trial within 3 months before screening
• People who used other uric acid-lowering medicines (such as allopurinol or probenecid) within 4 weeks before screening
• People who used certain medicines that interact with febuxostat (such as theophylline, azathioprine, or mercaptopurine) within 4 weeks before screening
• People taking aspirin at doses above 100 mg per day, or at an unstable dose, within 4 weeks before screening
• People who used diuretics (water tablets) within 2 weeks before joining
• People whose doses of certain blood pressure, cholesterol, or diabetes medicines were not stable in the 2 weeks before joining (confirm with trial site for specific medicines)
• Anyone the trial doctors consider unsuitable for other reasons

Important: Always verify eligibility with the trial site directly before applying.