A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

Gout Clinical Trial

— EPIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815901
• Other study ID #: JW21301
• Status: Recruiting
• Phase: Phase 3
• Start date: March 14, 2023
• Est. completion date: August 2025

Study information

• Verified date: April 2023
• Source: JW Pharmaceutical
• Contact: JW Pharmaceutical
• Phone: +82-2-840-6777
• Email: URC_CO[@]jw-group.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of subjects with sUA <6 mg/dL post-dose at each visit		up to Week 24
Secondary	Proportion of subjects with sUA <5 mg/dL at the last 3 time points		Week 16, 20, 24
Secondary	Proportion of subjects with sUA <5 mg/dL post-dose at each visit		up to Week 24
Secondary	Change from baseline in sUA (mg/dL) at each visit		up to Week 24
Secondary	Percent change from baseline in sUA at each visit		up to Week 24
Secondary	Incidence of gout flare post-dose up to Week 24		up to Week 24
Secondary	Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24		up to Week 24
Secondary	Adverse events	Safety endpoint	up to Week 52
Secondary	Number of subjects with clinical significant results of Laboratory tests	Safety endpoint	up to Week 52
Secondary	Number of subjects with clinical significant results of Vital signs	Safety endpoint	up to Week 52
Secondary	Number of subjects with clinical significant results of Electrocardiogram	Safety endpoint	up to Week 52