GoutPhase 3EPICNCT05815901
A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients
A Phase 3 study testing Epaminurad 6 mg, Epaminurad 9 mg and Febuxostat 40 mg in people with Gout, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gout
- What is being tested?
- Epaminurad 6 mg, Epaminurad 9 mg and Febuxostat 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 612 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Mar 2023to 23 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Medical history
- Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.
- 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
- History of gout flare between 2 weeks before written informed consent and immediately before randomization
- Any cardiovascular abnormalities that might affect the study
Show all 11Show fewer
- 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)
- Pregnant or lactating woman.
Trial locations and contacts
1 site in 1 country.
About this study
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
A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.
- Conditions
- Gout
- Being tested
- Epaminurad 6 mg, Epaminurad 9 mg, Febuxostat 40 mg, Febuxostat 80 mg, Epaminurad 6 mg placebo
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epaminurad 6 mgDrug
Epaminurad 6 mg tablet
Epaminurad 9 mgDrug
Epaminurad 9 mg tablet
Febuxostat 40 mgDrug
Febuxostat 40 mg tablet
Febuxostat 80 mgDrug
Febuxostat 80 mg tablet
Epaminurad 6 mg placeboDrug
Placebo tablet
Epaminurad 9 mg placeboDrug
Placebo tablet
Febuxostat 40 mg placeboDrug
Placebo tablet
Febuxostat 80 mg placeboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Epaminurad 6 mg | Experimental | [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. Receives: Drug: Epaminurad 6 mg; Drug: Epaminurad 9 mg placebo; Drug: Febuxostat 40 mg placebo; Drug: Febuxostat 80 mg placebo |
| Epaminurad 9 mg | Experimental | [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. Receives: Drug: Epaminurad 9 mg; Drug: Epaminurad 6 mg placebo; Drug: Febuxostat 40 mg placebo; Drug: Febuxostat 80 mg placebo |
| Febuxostat 40 mg | Active comparator | [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. Receives: Drug: Febuxostat 40 mg; Drug: Epaminurad 6 mg placebo; Drug: Epaminurad 9 mg placebo; Drug: Febuxostat 80 mg placebo |
| Febuxostat 80 mg | Active comparator | [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. Receives: Drug: Febuxostat 80 mg; Drug: Epaminurad 6 mg placebo; Drug: Epaminurad 9 mg placebo; Drug: Febuxostat 40 mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period
Measured: Week 24
Secondary outcomes (11)
Proportion of subjects with sUA <6 mg/dL post-dose at each visit
Measured: up to Week 24
Proportion of subjects with sUA <5 mg/dL at the last 3 time points
Measured: Week 16, 20, 24
Proportion of subjects with sUA <5 mg/dL post-dose at each visit
Measured: up to Week 24
Change from baseline in sUA (mg/dL) at each visit
Measured: up to Week 24
Percent change from baseline in sUA at each visit
Measured: up to Week 24
Incidence of gout flare post-dose up to Week 24
Measured: up to Week 24
Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24
Measured: up to Week 24
Adverse events
Safety endpoint
Measured: up to Week 52
Number of subjects with clinical significant results of Laboratory tests
Safety endpoint
Measured: up to Week 52
Number of subjects with clinical significant results of Vital signs
Safety endpoint
Measured: up to Week 52
Number of subjects with clinical significant results of Electrocardiogram
Safety endpoint
Measured: up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start21 Mar 2023
- Primary completion26 Mar 2024
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Won Park, MD, Study chair, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815901
- Sponsor's protocol ID
- JW21301
- Acronym
- EPIC
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05815901
- Acronym / sponsor ID
- EPIC / JW21301
- Conditions
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epaminurad 6 mg | Experimental | Drug: Epaminurad 6 mg, Drug: Epaminurad 9 mg placebo, Drug: Febuxostat 40 mg placebo, Drug: Febuxostat 80 mg placebo[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. |
| Epaminurad 9 mg | Experimental | Drug: Epaminurad 9 mg, Drug: Epaminurad 6 mg placebo, Drug: Febuxostat 40 mg placebo, Drug: Febuxostat 80 mg placebo[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. |
| Febuxostat 40 mg | Active comparator | Drug: Febuxostat 40 mg, Drug: Epaminurad 6 mg placebo, Drug: Epaminurad 9 mg placebo, Drug: Febuxostat 80 mg placebo[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. |
| Febuxostat 80 mg | Active comparator | Drug: Febuxostat 80 mg, Drug: Epaminurad 6 mg placebo, Drug: Epaminurad 9 mg placebo, Drug: Febuxostat 40 mg placebo[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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- for screening
- for randomization
Key exclusion criteria (11 listed)
- Medical history
- Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.
- 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
- History of gout flare between 2 weeks before written informed consent and immediately before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epaminurad 6 mgEpaminurad 6 mg tablet | Drug | Epaminurad 6 mg |
| Epaminurad 9 mgEpaminurad 9 mg tablet | Drug | Epaminurad 9 mg |
| Febuxostat 40 mgFebuxostat 40 mg tablet | Drug | Febuxostat 40 mg |
| Febuxostat 80 mgFebuxostat 80 mg tablet | Drug | Febuxostat 80 mg |
| Epaminurad 6 mg placeboPlacebo tablet | Drug | Epaminurad 9 mg, Febuxostat 40 mg, Febuxostat 80 mg |
| Epaminurad 9 mg placeboPlacebo tablet | Drug | Epaminurad 6 mg, Febuxostat 40 mg, Febuxostat 80 mg |
| Febuxostat 40 mg placeboPlacebo tablet | Drug | Epaminurad 6 mg, Epaminurad 9 mg, Febuxostat 80 mg |
| Febuxostat 80 mg placeboPlacebo tablet | Drug | Epaminurad 6 mg, Epaminurad 9 mg, Febuxostat 40 mg |
Primary outcome
Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period
Time frame: Week 24
11 secondary outcomes
Proportion of subjects with sUA <6 mg/dL post-dose at each visit
Time frame: up to Week 24
Proportion of subjects with sUA <5 mg/dL at the last 3 time points
Time frame: Week 16, 20, 24
Proportion of subjects with sUA <5 mg/dL post-dose at each visit
Time frame: up to Week 24
Change from baseline in sUA (mg/dL) at each visit
Time frame: up to Week 24
Percent change from baseline in sUA at each visit
Time frame: up to Week 24
Incidence of gout flare post-dose up to Week 24
Time frame: up to Week 24
Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24
Time frame: up to Week 24
Adverse events
Time frame: up to Week 52
Number of subjects with clinical significant results of Laboratory tests
Time frame: up to Week 52
Number of subjects with clinical significant results of Vital signs
Time frame: up to Week 52
Number of subjects with clinical significant results of Electrocardiogram
Time frame: up to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Park, MD study chair
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epaminurad 6 mg, Epaminurad 9 mg and Febuxostat 40 mg in people with Gout, run by JW Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.