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

• Sponsor: JW Pharmaceutical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05815901
• Collaborator: (none)
• Enrollment: 588
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 28.6
• Patients Per Site Per Month: 20.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gout	Drug: Epaminurad 6 mg; Drug: Epaminurad 9 mg; Drug: Febuxostat 40 mg; Drug: Febuxostat 80 mg; Drug: Epaminurad 6 mg placebo; Drug: Epaminurad 9 mg placebo; Drug: Febuxostat 40 mg placebo; Drug: Febuxostat 80 mg placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 588 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 14, 2023
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

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: Epaminurad 9 mg; Epaminurad 9 mg tablet; Drug: Epaminurad 6 mg placebo; Placebo tablet; Drug: Febuxostat 40 mg placebo; Placebo tablet; Drug: Febuxostat 80 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: Febuxostat 40 mg; Febuxostat 40 mg tablet; Drug: Epaminurad 6 mg placebo; Placebo tablet; Drug: Epaminurad 9 mg placebo; Placebo tablet; Drug: Febuxostat 80 mg placebo; Placebo 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: Febuxostat 80 mg; Febuxostat 80 mg tablet; Drug: Epaminurad 6 mg placebo; Placebo tablet; Drug: Epaminurad 9 mg placebo; Placebo tablet; Drug: Febuxostat 40 mg placebo; Placebo tablet

Outcome Measures

Primary Outcome Measures

1. 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

1. Proportion of subjects with sUA <6 mg/dL post-dose at each visit [up to Week 24]

2. Proportion of subjects with sUA <5 mg/dL at the last 3 time points [Week 16, 20, 24]

3. Proportion of subjects with sUA <5 mg/dL post-dose at each visit [up to Week 24]

4. Change from baseline in sUA (mg/dL) at each visit [up to Week 24]

5. Percent change from baseline in sUA at each visit [up to Week 24]

6. Incidence of gout flare post-dose up to Week 24 [up to Week 24]

7. Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24 [up to Week 24]

8. Adverse events [up to Week 52]

   Safety endpoint

9. Number of subjects with clinical significant results of Laboratory tests [up to Week 52]

   Safety endpoint

10. Number of subjects with clinical significant results of Vital signs [up to Week 52]

    Safety endpoint

11. Number of subjects with clinical significant results of Electrocardiogram [up to Week 52]

    Safety endpoint

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

1. 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

1. History of gout flare between 2 weeks before written informed consent and immediately before randomization

2. Any cardiovascular abnormalities that might affect the study

3. Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents

4. Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics

5. Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline

6. Hypersensitivity to the IP (epaminurad or febuxostat)

7. Pregnant or lactating woman.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inha University Hospital	Incheon		Korea, Republic of

Sponsors and Collaborators

• JW Pharmaceutical

Investigators

• Study Chair: Won Park, MD, Inha University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JW Pharmaceutical
• ClinicalTrials.gov Identifier: NCT05815901
• Other Study ID Numbers: JW21301
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gout; Febuxostat

Study Results

No Results Posted as of Apr 18, 2023