A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients (EPIC)

JW Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Gout

Treatments: Drug: Febuxostat 40 mg placebo; Drug: Epaminurad 9 mg placebo; Drug: Epaminurad 6 mg; Drug: Febuxostat 80 mg placebo; Drug: Epaminurad 6 mg placebo; Drug: Febuxostat 80 mg; Drug: Febuxostat 40 mg; Drug: Epaminurad 9 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05815901

JW21301

Details and patient eligibility

About

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

Enrollment: 588 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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588 participants in 4 patient groups

Epaminurad 6 mg

Experimental group

Description:

\[Main study period\] 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:

Drug: Febuxostat 80 mg placebo

Drug: Epaminurad 9 mg placebo

Drug: Febuxostat 40 mg placebo

Drug: Epaminurad 6 mg

Epaminurad 9 mg

Experimental group

Description:

\[Main study period\] 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:

Drug: Febuxostat 80 mg placebo

Drug: Epaminurad 6 mg placebo

Drug: Febuxostat 40 mg placebo

Drug: Epaminurad 9 mg

Febuxostat 40 mg

Active Comparator group

Description:

\[Main study period\] 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:

Drug: Febuxostat 80 mg placebo

Drug: Epaminurad 9 mg placebo

Drug: Epaminurad 6 mg placebo

Drug: Febuxostat 40 mg

Febuxostat 80 mg

Active Comparator group

Description:

\[Main study period\] 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:

Drug: Epaminurad 9 mg placebo

Drug: Epaminurad 6 mg placebo

Drug: Febuxostat 80 mg

Drug: Febuxostat 40 mg placebo