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

NCT06603142 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: APRAB-H001-P301
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Gout; Hyperuricemia

Keywords

ULT; Gout; Hyperuricemia; URAT1

Outcome Measures

Primary Outcomes (1)

• The percentage of participants with serum uric acid <360 μmol/L

  8 Weeks

Secondary Outcomes (6)

• 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

Study Arms (3)

AR882 50MG

EXPERIMENTAL

Titrated from 12.5 mg to 25 mg (2 weeks each), then 50 mg for 4 weeks, with matching Febuxostat placebo.

Drug: Febuxostat 20MG Placebo; Drug: AR882 25MG; Drug: AR882 12.5MG; Drug: Febuxostat 40MG Placebo

Febuxostat 40MG

ACTIVE COMPARATOR

Titrated from 20 mg (4 weeks) to 40 mg (4 weeks) Febuxostat, with matching AR882 placebo.

Drug: Febuxostat 20MG Tablets; Drug: AR882 25MG Placebo; Drug: AR882 12.5MG Placebo; Drug: Febuxostat 40MG Tablets

AR882 75MG

EXPERIMENTAL

Titrated from 25 mg to 50 mg (2 weeks each), then 75 mg for 4 weeks, with matching Febuxostat placebo.

Drug: Febuxostat 20MG Placebo; Drug: AR882 25MG; Drug: Febuxostat 40MG Placebo

Interventions

Febuxostat 20MG Tablets DRUG

Febuxostat 20MG Tablets

Febuxostat 40MG

Febuxostat 20MG Placebo DRUG

Febuxostat 20MG Placebo

AR882 50MG; AR882 75MG

AR882 25MG DRUG

AR882 25 MG Capsules

AR882 50MG; AR882 75MG

AR882 12.5MG DRUG

AR882 12.5 MG Capsules

AR882 50MG

AR882 25MG Placebo DRUG

AR882 25MG Placebo

Febuxostat 40MG

AR882 12.5MG Placebo DRUG

AR882 12.5MG Placebo

Febuxostat 40MG

Febuxostat 40MG Tablets DRUG

Febuxostat 40MG Tablets

Febuxostat 40MG

Febuxostat 40MG Placebo DRUG

Febuxostat 40MG Placebo

AR882 50MG; AR882 75MG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science

Beijing, 100730, China

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: April 22, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)