Comparing Epaminurad and Febuxostat for treating gout
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
This study is testing whether a new gout medication called epaminurad works better than an existing treatment called febuxostat to help people manage their gout symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 588 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | JW Pharmaceutical Industry-sponsored |
| Locations | 1 site (Incheon) |
| Trial ID | NCT05815901 on ClinicalTrials.gov |
What this trial studies
This phase 3 clinical trial aims to compare the efficacy and safety of epaminurad against febuxostat in patients diagnosed with gout. Participants will receive either epaminurad at doses of 6 mg or 9 mg, febuxostat at doses of 40 mg or 80 mg, or a placebo. The study will evaluate the impact of these treatments on serum uric acid levels and overall gout management. Eligible participants must be between 19 and 75 years old and have a documented diagnosis of gout.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 to 75 with a confirmed diagnosis of gout and elevated serum uric acid levels.
Not a fit: Patients with uncontrolled comorbidities or recent gout flares may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from gout.
How similar studies have performed: Previous studies have shown promising results with similar medications for gout, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Incheon
- Inha University Hospital — Incheon, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: JW Pharmaceutical
- Email: URC_CO@jw-group.co.kr
- Phone: +82-2-840-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.