Phase 3 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:

• You are 18 years old or older
• Your body weight falls within a moderate range (BMI between 18 and 40)
• You have been diagnosed with gout using recognised medical guidelines
• Your blood uric acid level is above a certain threshold at the screening visit — the exact level depends on whether you have other health conditions (confirm with trial site)
• You are willing to sign a consent form and agree to follow all study requirements

Who may not be able to join:

• You have had an allergic reaction or bad response to either of the study medications (febuxostat or Tigulixostat) in the past
• You have had a gout flare-up within the 4 weeks before or around the time of your first study dose
• You have taken uric acid-lowering medicines within 2 weeks before your screening visit
• Your high uric acid is caused by another underlying condition such as cancer, organ transplant, or certain other diseases (though high uric acid due to kidney problems may still be allowed — confirm with trial site)
• You have recently had dose changes to certain common medicines that can affect uric acid levels, such as some blood pressure, cholesterol, or diabetes drugs (confirm with trial site)
• You take long-term medicines that are broken down by a specific enzyme affected by the study drug, such as azathioprine or mercaptopurine
• You have taken steroid tablets for 10 or more days in a row, or had steroid injections within the past 4 weeks
• You have received certain biological/immune-system medicines within the past 12 weeks
• You have certain rare inherited conditions affecting how your body processes uric acid (confirm with trial site)
• You have severe uncontrolled pain not related to gout
• You have had a serious heart or stroke-related event within the past 6 months, such as a heart attack, unstable chest pain, or severe heart failure
• You have an abnormal heart rhythm reading (QTcF ≥ 480 ms) or a history of a specific heart electrical problem (confirm with trial site)
• Your blood pressure is poorly controlled (above 160/100 mmHg) or your blood pressure medicines have recently been changed
• Your diabetes is poorly controlled, based on a blood test result (HbA1c of 9.0% or above)
• You have an autoimmune or inflammatory disease that needs immune-suppressing treatment
• You have an active stomach ulcer or have had gut bleeding within the past month
• You have a condition that seriously affects how your body absorbs medicines, such as irritable bowel disease
• You have an active infection with hepatitis B, hepatitis C, HIV, or syphilis
• You have had an active or untreated cancer within the past 5 years (some low-risk cancers may be exceptions — confirm with trial site)
• You have a thyroid condition that requires treatment
• Your liver function blood tests are significantly abnormal
• Your kidney function is significantly reduced (eGFR below 30 — confirm with trial site)
• You are pregnant, breastfeeding, or unwilling to use reliable contraception during the study and for 8 weeks afterwards
• You drink more than a certain amount of alcohol each week (more than 21 units per week for men, more than 14 units per week for women)
• You have donated or lost a large amount of blood (400 mL or more) in the past 3 months, or have had a blood transfusion
• You are currently in, or have recently taken part in, another clinical trial within the past 3 months
• You have had major surgery within the past 3 months, have not fully recovered, or are planning major surgery during the study
• You have a mental health condition that the study doctor believes makes participation unsuitable
• You have any other health condition that the study doctor believes could affect the study results or your safety

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