A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Febuxostat

Criteria

Inclusion Criteria:

• for screening

1. ≥19 to ≤75 years of age at the time of written informed consent

2. Diagnosed record with gout, or ACR/EULAR 2015 score ≥8

3. Able and willing to actively participate in TLC programme

4. Signed ICF for voluntary study participation

• for randomization

1. sUA level ≥7.0 mg/dL

2. ACR/EULAR 2015 score ≥8

Exclusion Criteria:

1. Medical history

Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.

2. Concurrent disease or laboratory test abnormality

Uncontrolled diabetes mellitus, Uncontrolled hypertension, Uncontrolled dyslipidemia, AST or ALT ≥2×ULN, total bilirubin ≥1.5×ULN, eGFR <30 mL/min/1.73m^2, Uncontrolled thyroid dysfunction, HIV, HBV or HCV positive, Drug and alcohol abuse, BMI ≥40 kg/m^2

3. History of gout flare between 2 weeks before written informed consent and immediately before randomization

4. Any cardiovascular abnormalities that might affect the study

5. Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents

6. Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics

7. Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline

8. Hypersensitivity to the IP (epaminurad or febuxostat)

9. Pregnant or lactating woman.