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

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.

Study Overview

• Status: Recruiting
• Conditions: Gout
• Intervention / Treatment: Drug: Epaminurad 6 mg; Drug: Epaminurad 9 mg placebo; Drug: Febuxostat 40 mg placebo; Drug: Febuxostat 80 mg placebo; Drug: Epaminurad 9 mg; Drug: Epaminurad 6 mg placebo; Drug: Febuxostat 40 mg; Drug: Febuxostat 80 mg

• Study Type: Interventional
• Enrollment (Anticipated): 588
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: JW Pharmaceutical; Phone Number: +82-2-840-6777; Email: URC_CO@jw-group.co.kr

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Recruiting
    • Inha University Hospital
    • Contact: Won Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epaminurad 6 mg; [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.	Drug: Epaminurad 6 mg; Epaminurad 6 mg tablet; Drug: Epaminurad 9 mg placebo; Placebo tablet; Drug: Febuxostat 40 mg placebo; Placebo tablet; Drug: Febuxostat 80 mg placebo; Placebo tablet
Experimental: Epaminurad 9 mg; [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.	Drug: Febuxostat 40 mg placebo; Placebo tablet; Drug: Febuxostat 80 mg placebo; Placebo tablet; Drug: Epaminurad 9 mg; Epaminurad 9 mg tablet; Drug: Epaminurad 6 mg placebo; Placebo tablet
Active Comparator: Febuxostat 40 mg; [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.	Drug: Epaminurad 9 mg placebo; Placebo tablet; Drug: Febuxostat 80 mg placebo; Placebo tablet; Drug: Epaminurad 6 mg placebo; Placebo tablet; Drug: Febuxostat 40 mg; Febuxostat 40 mg tablet
Active Comparator: Febuxostat 80 mg; [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.	Drug: Epaminurad 9 mg placebo; Placebo tablet; Drug: Febuxostat 40 mg placebo; Placebo tablet; Drug: Epaminurad 6 mg placebo; Placebo tablet; Drug: Febuxostat 80 mg; Febuxostat 80 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with sUA <6 mg/dL post-dose at each visit		up to Week 24
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 who had rescue therapy for gout flare post-dose up to Week 24		up to Week 24
Adverse events	Safety endpoint	up to Week 52
Number of subjects with clinical significant results of Laboratory tests	Safety endpoint	up to Week 52
Number of subjects with clinical significant results of Vital signs	Safety endpoint	up to Week 52
Number of subjects with clinical significant results of Electrocardiogram	Safety endpoint	up to Week 52

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Study Chair: Won Park, MD, Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: JW21301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No