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

Launched by GUANGZHOU RUIANBO PHARMACEUTICAL TECHNOLOGY CO., LTD · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AR882 Capsules to see how well it works compared to an existing medication, Febuxostat Tablets, for patients with primary gout and high uric acid levels (a condition known as hyperuricemia). The main goal is to find out if AR882 can lower uric acid levels in the blood more effectively and safely than Febuxostat. The trial is divided into two parts: the first part will help determine the best dose for the next stage, and the second part will evaluate the overall effectiveness of AR882.

To be eligible for this trial, participants must be between 18 and 75 years old and have a history of gout with high uric acid levels. They should be willing to take either AR882 Capsules or Febuxostat Tablets and participate in regular check-ups to monitor their uric acid levels. Participants will also need to report any side effects they experience during the study. It’s important to know that this trial is currently active but not recruiting new participants. If you have any questions about your eligibility or the trial details, it's best to discuss them with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female patients ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF)；
• • History of gout according to the 2015 American College Rheumatology/European League Against 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 accepted effective 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 previous intolerance or contraindications to febuxostat；
• • HbA1c ≥8% within 2 weeks prior to randomization；
• • Any of the following laboratory test results within 2 weeks prior to randomization：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 uric acid levels (including but not limited to losartan, calcium channel blockers, fenofibrate, atorvastatin, α-glucosidase inhibitors, insulin sensitizers, DPP4 inhibitors, 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 to randomization；
• • 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, hematological diseases, 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 or urolithiasis 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, systemic lupus erythematosus, or joint diseases caused by chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive nephropathy, etc.;
• • Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin and resected cervical intraepithelial neoplasia that has been successfully treated；
• • Severe cardiovascular or cerebrovascular diseases, such as New York Heart Association (NYHA) Class III-IV congestive heart failure, uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), QTcF interval (Fridericia\'s formula) prolongation (male \>450 ms, female \>470 ms), myocardial infarction, acute stroke, uncontrolled arrhythmia, or unstable angina within 12 months prior to screening；
• • Unable to swallow oral medications or have gastrointestinal diseases that may interfere with drug absorption, or have active gastric or duodenal ulcers within 3 months prior to screening；
• • Systemic diseases requiring immunosuppressive therapy, or vaccination within 2 weeks prior to randomization；
• • Other severe or uncontrolled diseases；
• • History of xanthinuria；
• • Poor compliance (e.g., alcoholism, drug abuse) that may affect the safety and efficacy 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 for serum 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 surgery during the study；
• • Blood donation (or blood loss) ≥400 mL or blood transfusion within 3 months prior to randomization；
• • Participation in another drug clinical trial within 3 months prior to screening or within 5 half-lives of the investigational product (whichever is longer), or participation in a medical device clinical trial within 3 months prior to screening；
• • Any other condition deemed unsuitable for study participation by the investigator