A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

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

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

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epaminurad 6 mg<br>[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<br>* Epaminurad 6 mg tablet<br>Drug: Epaminurad 9 mg placebo<br>* Placebo tablet<br>Drug: Febuxostat 40 mg placebo<br>* Placebo tablet<br>Drug: Febuxostat 80 mg placebo<br>* Placebo tablet<br>|
| Experimental: Epaminurad 9 mg<br>[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<br>* Epaminurad 9 mg tablet<br>Drug: Epaminurad 6 mg placebo<br>* Placebo tablet<br>Drug: Febuxostat 40 mg placebo<br>* Placebo tablet<br>Drug: Febuxostat 80 mg placebo<br>* Placebo tablet<br>|
| Active Comparator: Febuxostat 40 mg<br>[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<br>* Febuxostat 40 mg tablet<br>Drug: Epaminurad 6 mg placebo<br>* Placebo tablet<br>Drug: Epaminurad 9 mg placebo<br>* Placebo tablet<br>Drug: Febuxostat 80 mg placebo<br>* Placebo tablet<br>|
| Active Comparator: Febuxostat 80 mg<br>[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<br>* Febuxostat 80 mg tablet<br>Drug: Epaminurad 6 mg placebo<br>* Placebo tablet<br>Drug: Epaminurad 9 mg placebo<br>* Placebo tablet<br>Drug: Febuxostat 40 mg placebo<br>* Placebo tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |