A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients
Key facts
- Who runs it
- JW Pharmaceutical
- Where
- South Korea1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 612 people enrolled
- Started
- 21 Mar 2023
- Ended
- 23 Apr 2026
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Epaminurad 6 mg
- Epaminurad 9 mg
- Febuxostat 40 mg
- Febuxostat 80 mg
- Epaminurad 6 mg placebo
- Epaminurad 9 mg placebo
- Febuxostat 40 mg placebo
- Febuxostat 80 mg placebo
- Record updated
- 4 May 2026
Who can take part
- Age
- 19 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- for screening; ≥19 to ≤75 years of age at the time of written informed consent; Diagnosed record with gout, or ACR/EULAR 2015 score ≥8; Able and willing to actively participate in TLC programme; Signed ICF for voluntary study participation
- for randomization; sUA level ≥7.0 mg/dL; ACR/EULAR 2015 score ≥8
Who cannot take part
- Medical history; Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient
- History of gout flare between 2 weeks before written informed consent and immediately before randomization
- Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents
- Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics
- Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline
- Hypersensitivity to the IP (epaminurad or febuxostat)
- 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
- Any cardiovascular abnormalities that might affect the study
- Pregnant or lactating woman
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.
The 4 groups in the trial
- Epaminurad 6 mgTreatment being tested
\[Main study period\] Epaminurad 6 mg and three matched placebos for 20 weeks. \[Extension study period\] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
Treatment: Epaminurad 6 mg, Epaminurad 9 mg placebo, Febuxostat 40 mg placebo, and Febuxostat 80 mg placebo
- Epaminurad 9 mgTreatment being tested
\[Main study period\] Epaminurad 9 mg and three matched placebos for 20 weeks. \[Extension study period\] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
Treatment: Epaminurad 9 mg, Epaminurad 6 mg placebo, Febuxostat 40 mg placebo, and Febuxostat 80 mg placebo
- Febuxostat 40 mgExisting treatment, for comparison
\[Main study period\] Febuxostat 40 mg and three matched placebos for 20 weeks. \[Extension study period\] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
Treatment: Febuxostat 40 mg, Epaminurad 6 mg placebo, Epaminurad 9 mg placebo, and Febuxostat 80 mg placebo
- Febuxostat 80 mgExisting treatment, for comparison
\[Main study period\] Febuxostat 80 mg and three matched placebos for 20 weeks. \[Extension study period\] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
Treatment: Febuxostat 80 mg, Epaminurad 6 mg placebo, Epaminurad 9 mg placebo, and Febuxostat 40 mg placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multi-center, Randomized, Double-blind, Active-controlled, Therapeutic Confirmatory, Phase III Study to Compare and Evaluate the Efficacy and Safety of Epaminurad With Febuxostat in Gout Patients
- Record updated
- 4 May 2026