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

Primary Purpose

Gout

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epaminurad 6 mg
Epaminurad 9 mg
Febuxostat 40 mg
Febuxostat 80 mg
Epaminurad 6 mg placebo
Epaminurad 9 mg placebo
Febuxostat 40 mg placebo
Febuxostat 80 mg placebo
Sponsored by
JW Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Sites / Locations

  • Inha University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Epaminurad 6 mg

Epaminurad 9 mg

Febuxostat 40 mg

Febuxostat 80 mg

Arm 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.

[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.

[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.

[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.

Outcomes

Primary Outcome Measures

Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2023
Last Updated
April 4, 2023
Sponsor
JW Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05815901
Brief Title
A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
588 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epaminurad 6 mg
Arm Type
Experimental
Arm 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.
Arm Title
Epaminurad 9 mg
Arm Type
Experimental
Arm 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.
Arm Title
Febuxostat 40 mg
Arm Type
Active Comparator
Arm 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.
Arm Title
Febuxostat 80 mg
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Epaminurad 6 mg
Intervention Description
Epaminurad 6 mg tablet
Intervention Type
Drug
Intervention Name(s)
Epaminurad 9 mg
Intervention Description
Epaminurad 9 mg tablet
Intervention Type
Drug
Intervention Name(s)
Febuxostat 40 mg
Intervention Description
Febuxostat 40 mg tablet
Intervention Type
Drug
Intervention Name(s)
Febuxostat 80 mg
Intervention Description
Febuxostat 80 mg tablet
Intervention Type
Drug
Intervention Name(s)
Epaminurad 6 mg placebo
Intervention Description
Placebo tablet
Intervention Type
Drug
Intervention Name(s)
Epaminurad 9 mg placebo
Intervention Description
Placebo tablet
Intervention Type
Drug
Intervention Name(s)
Febuxostat 40 mg placebo
Intervention Description
Placebo tablet
Intervention Type
Drug
Intervention Name(s)
Febuxostat 80 mg placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Proportion of subjects with sUA <6 mg/dL post-dose at each visit
Time Frame
up to Week 24
Title
Proportion of subjects with sUA <5 mg/dL at the last 3 time points
Time Frame
Week 16, 20, 24
Title
Proportion of subjects with sUA <5 mg/dL post-dose at each visit
Time Frame
up to Week 24
Title
Change from baseline in sUA (mg/dL) at each visit
Time Frame
up to Week 24
Title
Percent change from baseline in sUA at each visit
Time Frame
up to Week 24
Title
Incidence of gout flare post-dose up to Week 24
Time Frame
up to Week 24
Title
Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24
Time Frame
up to Week 24
Title
Adverse events
Description
Safety endpoint
Time Frame
up to Week 52
Title
Number of subjects with clinical significant results of Laboratory tests
Description
Safety endpoint
Time Frame
up to Week 52
Title
Number of subjects with clinical significant results of Vital signs
Description
Safety endpoint
Time Frame
up to Week 52
Title
Number of subjects with clinical significant results of Electrocardiogram
Description
Safety endpoint
Time Frame
up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JW Pharmaceutical
Phone
+82-2-840-6777
Email
URC_CO@jw-group.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Park, MD
Organizational Affiliation
Inha University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Park, MD

12. IPD Sharing Statement

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A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

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