Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia

Inclusion Criteria:

• Male or female patients ≥ 18 and ≤ 75 years of age at the time of signing theinformed consent form (ICF)；

• History of gout according to the 2015 American College Rheumatology/European LeagueAgainst Rheumatism (ACR/EULAR) Gout Classification Criteria，with serum urate (sUA)levels ≥480μmol/L；

• Body mass index (BMI) must be within the range of ≥ 18 to ≤ 35 kg/m2；

• Participants with childbearing potential must agree to use medically acceptedeffective contraception during the study period and for 3 months after the last dose

• Willing to participate in the study and sign the informed consent form.

Exclusion Criteria:

• Known or suspected allergy to the study drug or its components, or previousintolerance or contraindications to febuxostat；

• HbA1c ≥8% within 2 weeks prior to randomization；

• Any of the following laboratory test results within 2 weeks prior torandomization：WBC<3.0×109/L，Hb<90g/L，PLT<80×109/L，ASTorALT>1.5×ULN，TBIL>1.5×ULN，Scr>1.5×ULN，eGFR<60mL/min/1.73m2；

• Use of any other uric acid-lowering drugs or concomitant medications affecting uricacid levels (including but not limited to losartan, calcium channel blockers,fenofibrate, atorvastatin, α-glucosidase inhibitors, insulin sensitizers, DPP4inhibitors, SGLT2 inhibitors, metformin) within 2 weeks prior to randomization,except for stable dose usage；

• Use of aspirin >100 mg/day or unstable dosage within 2 weeks prior torandomization；

• Use of any diuretics within 2 weeks prior to randomization；

• Use of a strong or moderate CYP2C9 inhibitor or BCRP substrate drugs (see Appendix

2. within 2 weeks prior to randomization；

• Secondary hyperuricemia due to tumors, chronic kidney disease, hematologicaldiseases, medications, or hereditary hyperuricemia；

• Presence of unresolved gout attacks within 2 weeks prior to randomization；

• Imaging or clinical manifestations (e.g., hematuria, back pain) of kidney stones orurolithiasis within 2 weeks prior to randomization；

• Other joint lesions that may confound gouty arthritis, such as rheumatoid arthritis,septic arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, systemiclupus erythematosus, or joint diseases caused by chemotherapy, radiotherapy, chroniclead poisoning, acute obstructive nephropathy, etc.;

• Malignancy within 5 years, except for basal or squamous cell carcinoma of the skinand resected cervical intraepithelial neoplasia that has been successfully treated；

• Severe cardiovascular or cerebrovascular diseases, such as New York HeartAssociation (NYHA) Class III-IV congestive heart failure, uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), QTcFinterval (Fridericia's formula) prolongation (male >450 ms, female >470 ms), myocardial infarction, acute stroke, uncontrolled arrhythmia, orunstable angina within 12 months prior to screening；

• Unable to swallow oral medications or have gastrointestinal diseases that mayinterfere with drug absorption, or have active gastric or duodenal ulcers within 3months prior to screening；

• Systemic diseases requiring immunosuppressive therapy, or vaccination within 2 weeksprior to randomization；

• Other severe or uncontrolled diseases；

• History of xanthinuria；

• Poor compliance (e.g., alcoholism, drug abuse) that may affect the safety andefficacy evaluation of the study drug, as judged by the investigator；

• Pregnant or breastfeeding women；

• Any acute inflammation or clinically significant active infection；

• Active hepatitis B (HBsAg positive and HBV-DNA >1000 IU/mL), or positive forserum HCV antibodies, HIV antibodies, or syphilis antibodies；

• Previous kidney removal and/or kidney transplantation；

• Major surgery within 3 months prior to randomization, or planned major surgeryduring the study；

• Blood donation (or blood loss) ≥400 mL or blood transfusion within 3 months prior torandomization；

• Participation in another drug clinical trial within 3 months prior to screening orwithin 5 half-lives of the investigational product (whichever is longer), orparticipation in a medical device clinical trial within 3 months prior to screening；

• Any other condition deemed unsuitable for study participation by the investigator