Gout
Conditions
Brief summary
A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.
Interventions
DRUGFebuxostat 80 mg
Febuxostat 80 mg tablet
DRUGEpaminurad 6 mg placebo
Placebo tablet
DRUGEpaminurad 9 mg placebo
Placebo tablet
DRUGFebuxostat 40 mg placebo
Placebo tablet
DRUGFebuxostat 80 mg placebo
Placebo tablet
DRUGEpaminurad 6 mg
Epaminurad 6 mg tablet
DRUGEpaminurad 9 mg
Epaminurad 9 mg tablet
DRUGFebuxostat 40 mg
Febuxostat 40 mg tablet
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period | Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with sUA <5 mg/dL at the last 3 time points | Week 16, 20, 24 | — |
| Proportion of subjects with sUA <5 mg/dL post-dose at each visit | up to Week 24 | — |
| Change from baseline in sUA (mg/dL) at each visit | up to Week 24 | — |
| Percent change from baseline in sUA at each visit | up to Week 24 | — |
| Incidence of gout flare post-dose up to Week 24 | up to Week 24 | — |
| Proportion of subjects with sUA <6 mg/dL post-dose at each visit | up to Week 24 | — |
| Adverse events | up to Week 52 | Safety endpoint |
| Number of subjects with clinical significant results of Laboratory tests | up to Week 52 | Safety endpoint |
| Number of subjects with clinical significant results of Vital signs | up to Week 52 | Safety endpoint |
| Number of subjects with clinical significant results of Electrocardiogram | up to Week 52 | Safety endpoint |
| Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24 | up to Week 24 | — |
Countries
South Korea
Contacts
Primary ContactJW Pharmaceutical
Outcome results
None listed