The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time

The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time: A Multicenter, Randomized, Parallel-Controlled Study

To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.

To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients. At the same time, to compare whether there are differences in the uric acid-lowering effects of initiating Dotinurad treatment at different times.And to evaluate the safety and tolerability of the treatment regimen.

Inclusion Criteria:

• Male or female individuals aged 18-70 years old.
• Meet the 2015 ACR/EULAR diagnostic criteria of gout.
• With an onset of acute gout flares within 7 days.
• With gout experiencing gout flares ≥2 times; or with gout experiencing gout flares 1 time and is younger than 40 years old; or with gout experiencing gout flares 1 time and has a serum uric acid level greater than 480 μmol/L and/or has co-morbidities (renal function impairment, hypertension,).
• Provide a signed written informed consent form.

Exclusion Criteria:

• Has secondary hyperuricemia.
• Serum uric acid level < 360 μmol/L.
• Used IL-1β inhibitors within 6 months before screening.
• Used uric acid-lowering drugs within 1 month before screening.
• Used anti-inflammatory drugs within 14 days before screening.
• Comorbidities with nephrolithiasis or clinical urinary calculi
• History of kidney transplantation or dialysis.
• Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m².
• AST or ALT > 2 times the upper limit of normal.
• Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg during the screening period.
• White blood cell count < 3.5 × 10⁹/L, or platelet count < 100 × 10⁹/L, or hemoglobin < 90 g/L.
• Currently in the treatment period of malignant tumors, or within 6 months after the end of the treatment period.
• Congestive heart failure (New York Heart Association [NYHA] cardiac function classification II-IV), confirmed ischemic heart disease, peripheral artery disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).
• Hypersensitivity to the study drugs or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations).
• Have active gastrointestinal ulcers/bleeding, or have had a recurrence of ulcers/bleeding in the past.