A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
Overview
- Phase
- Phase 2
- Intervention
- Febuxostat 20MG Placebo
- Conditions
- Primary Gout
- Sponsor
- Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd
- Enrollment
- 636
- Locations
- 1
- Primary Endpoint
- The percentage of participants with serum uric acid <360 μmol/L
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia. The main questions it aims to answer are:
What is the efficacy of AR882 Capsules in reducing serum uric acid levels in patients with primary gout and hyperuricemia?
Researchers will compare AR882 Capsules with Febuxostat Tablets to see :
Phase II: To explore the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia, aiming to determine the dosing regimen for the Phase III study Phase III: To evaluate the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia.
Participants will:
Be randomly assigned to receive either AR882 Capsules or Febuxostat Tablets. Undergo regular assessments of serum uric acid levels. Report any adverse events or side effects experienced during the study.
Investigators
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 \&amp;gt;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；
Arms & Interventions
AR882 50MG
Titrated from 12.5 mg to 25 mg (2 weeks each), then 50 mg for 4 weeks, with matching Febuxostat placebo.
Intervention: Febuxostat 20MG Placebo
AR882 50MG
Titrated from 12.5 mg to 25 mg (2 weeks each), then 50 mg for 4 weeks, with matching Febuxostat placebo.
Intervention: AR882 25MG
AR882 50MG
Titrated from 12.5 mg to 25 mg (2 weeks each), then 50 mg for 4 weeks, with matching Febuxostat placebo.
Intervention: AR882 12.5MG
AR882 50MG
Titrated from 12.5 mg to 25 mg (2 weeks each), then 50 mg for 4 weeks, with matching Febuxostat placebo.
Intervention: Febuxostat 40MG Placebo
Febuxostat 40MG
Titrated from 20 mg (4 weeks) to 40 mg (4 weeks) Febuxostat, with matching AR882 placebo.
Intervention: Febuxostat 20MG Tablets
Febuxostat 40MG
Titrated from 20 mg (4 weeks) to 40 mg (4 weeks) Febuxostat, with matching AR882 placebo.
Intervention: AR882 25MG Placebo
Febuxostat 40MG
Titrated from 20 mg (4 weeks) to 40 mg (4 weeks) Febuxostat, with matching AR882 placebo.
Intervention: AR882 12.5MG Placebo
Febuxostat 40MG
Titrated from 20 mg (4 weeks) to 40 mg (4 weeks) Febuxostat, with matching AR882 placebo.
Intervention: Febuxostat 40MG Tablets
AR882 75MG
Titrated from 25 mg to 50 mg (2 weeks each), then 75 mg for 4 weeks, with matching Febuxostat placebo.
Intervention: Febuxostat 20MG Placebo
AR882 75MG
Titrated from 25 mg to 50 mg (2 weeks each), then 75 mg for 4 weeks, with matching Febuxostat placebo.
Intervention: AR882 25MG
AR882 75MG
Titrated from 25 mg to 50 mg (2 weeks each), then 75 mg for 4 weeks, with matching Febuxostat placebo.
Intervention: Febuxostat 40MG Placebo
Outcomes
Primary Outcomes
The percentage of participants with serum uric acid <360 μmol/L
Time Frame: 8 Weeks
Secondary Outcomes
- The percentage of participants with serum uric acid <300, 240 μmol/L(8 Weeks)
- The percentage of participants with serum uric acid <360, 300, 240 μmol/L(2, 4, and 6 Weeks)
- The absolute change in serum uric acid levels from baseline(2, 4, 6, and 8 Weeks)
- The percentage change in serum uric acid levels from baseline(2, 4, 6, and 8 Weeks)
- Serum uric acid levels(2, 4, 6, and 8 Weeks)
- Adverse events(8 Weeks)