Clinical Trials List
Protocol NumberJW21301
Active
2022-12-14 - 2026-01-01
Phase III
Not yet recruiting1
Recruiting12
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
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/06
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳彥輔 無
- 蕭朝陽醫師 無
- 張哲慈 無
- Yun Chen Tsai 無
- Shue-Fen Lo 無
- 黃思偉 無
- 謝孟儒醫師 無
- 尤瀚華醫師 無
- Yun Ju Huang 無
- Chen-I Hsieh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳英州 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳全裕醫師 無
- Meng-Yu Weng 無
- 黃雅君醫師 無
- 吳至行醫師 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
WEN-NAN HUANG
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
gout
Objectives
Epaminurad tablets are an investigational drug currently undergoing clinical trials. There is currently no regulatory body approving its widespread use. Seven clinical trials, including Phase 1 and Phase 2 trials, have been conducted in healthy adults, adults with renal insufficiency, and adults with gout to evaluate the safety and efficacy of epaminurad tablets.
This Phase 3 trial aims to confirm its effect on lowering serum uric acid and the safety of epaminurad tablets in patients with gout compared to febuxostat.
Test Drug
Epaminurad
Active Ingredient
Epaminurad
Dosage Form
tablet
Dosage
6mg and 9mg
Endpoints
Based on the reduction of serum uric acid (sUA) in gout patients, epaminurad tablets (hereinafter referred to as "epaminurad") were evaluated as non-inferior to febuxostat.
Inclution Criteria
To be eligible to participate in the trial, participants must meet all of the following criteria: Screening Inclusion Criteria
1) Age ≥ 19 to 75 years at the time of obtaining written informed consent.
(Note: Due to local age requirements in Taiwan, participation is limited to patients aged 20 and above as of December 31, 2022.)
2) A history of gout diagnosis, or an ACR EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) 2015 gout classification score ≥ 8.
3) Ability and willingness to actively participate in the therapeutic lifestyle change (TLC) recommended in the trial. 4) Sign the Informed Consent Form (ICF) for Voluntary Participation in the Trial
Randomization Inclusion Criteria
1) Serum uric acid (sUA) concentration at the second follow-up screening visit ≥ 7.0 mg/dL
2) ACR/EULAR 2015 gout classification score at the second follow-up screening visit ≥ 8. Subjects meeting any of the following criteria are not allowed to participate in the trial:
1) Medical history or comorbidities confirmed at screening:
(1) Malignant tumors within 5 years prior to screening
(2) Urinary tract stones
(3) Clinically significant allergic reactions (anaphylactic shock, etc.)
(4) Lesch-Nyhan syndrome
(5) Genetic problems, such as lactose intolerance, Lapp lactase deficiency, or glucose-lactose malabsorption, etc.
(6) Ischemic heart disease (6... Unstable medical history within the past month, including acute coronary syndrome and myocardial infarction) or severe heart failure (*NYHA Class 3 or 4) *New York Heart Association (7) Previous or planned organ transplant recipient (8) Body mass index (BMI) ≥ 40 kg/m2 2) Coexisting diseases or abnormal laboratory test results confirmed at screening (1) Uncontrolled diabetes - HbA1c ≥ 9% (2) Uncontrolled hypertension - Systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (3) Uncontrolled dyslipidemia - Total cholesterol ≥ 250 mg/dL (after fasting for at least 8 hours) (4) Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 2 • Upper limit of normal (ULN) or total bilirubin ≤ 1.5 ≤ ULN
(5) Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 (using the modified diet for renal disease (MDRD) formula)
(6) Uncontrolled thyroid dysfunction - Thyroid-stimulating hormone (TSH) ≤ 1.5 ≤ ULN
(7) Positive results for human immunodeficiency virus antigen and antibody (HIV Ag/Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at screening. (8) History of drug and alcohol abuse within 5 years prior to screening (before the first follow-up visit); or alcohol dependence as assessed by the AUDIT-C questionnaire
3) History of gout attack within 2 weeks prior to written informed consent and shortly before randomization (the third follow-up visit)
4) According to the trial administrator's judgment, any cardiovascular abnormalities or potential exposure to cardiovascular risks on a 12-lead electrocardiogram (ECG) at screening (the first follow-up visit) that may affect the trial
5) Treatment with a xanthine oxidation inhibitor (XOI) or uricosuric drug within 3 weeks prior to administration of the investigational drug (IP) (the third follow-up visit) or planned treatment
6) Treatment with a drug acting on human uric acid transporter 1 (hURAT1) (indomethacin, ...) within 2 weeks prior to administration of the investigational drug (IP) (the third follow-up visit) or planned treatment pyrazinamide, fenofibrate, losartan, captopril, salicylates, etc.) or diuretic treatment
In exceptional cases, the following medications may continue to be used during the trial period if the dosage remains unchanged:
(1) Diuretics for treating hypertension (thiazide monotherapy or thiazide-based combination therapy) and antihypertensive drugs (e.g., losartan, etc.)
(2) Fenofibrates for treating hyperlipidemia
(3) Salicylates (aspirin)
7) Within 1 week prior to screening (first follow-up visit) or within 5 times the half-life, or before planned treatment with mercaptopurine, azathioprine, or theophylline, whichever is longer
8) Hypersensitivity to the investigational drug (IP) (epaminurad or febuxostat) or any of its components
9) Having received another medication within 4 weeks prior to screening (first follow-up visit) Treatment with the investigational drug (IP) or investigational device, or currently participating in another clinical trial
10) Pregnant or breastfeeding women
11) Individuals who do not agree to continue using a medically acceptable method of contraception for at least 28 days during and after the trial (EOS)
*Contraceptive methods: Intrauterine device or intrauterine system implantation, Double barrier method (spermicide condom with diaphragm, vaginal sponge or cervical cap), Surgical sterilization (vasectomy, bilateral tubal ligation, etc.)
12) Individuals deemed unsuitable for the trial and continued participation for other reasons, based on the trial administrator's judgment.
1) Age ≥ 19 to 75 years at the time of obtaining written informed consent.
(Note: Due to local age requirements in Taiwan, participation is limited to patients aged 20 and above as of December 31, 2022.)
2) A history of gout diagnosis, or an ACR EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) 2015 gout classification score ≥ 8.
3) Ability and willingness to actively participate in the therapeutic lifestyle change (TLC) recommended in the trial. 4) Sign the Informed Consent Form (ICF) for Voluntary Participation in the Trial
Randomization Inclusion Criteria
1) Serum uric acid (sUA) concentration at the second follow-up screening visit ≥ 7.0 mg/dL
2) ACR/EULAR 2015 gout classification score at the second follow-up screening visit ≥ 8. Subjects meeting any of the following criteria are not allowed to participate in the trial:
1) Medical history or comorbidities confirmed at screening:
(1) Malignant tumors within 5 years prior to screening
(2) Urinary tract stones
(3) Clinically significant allergic reactions (anaphylactic shock, etc.)
(4) Lesch-Nyhan syndrome
(5) Genetic problems, such as lactose intolerance, Lapp lactase deficiency, or glucose-lactose malabsorption, etc.
(6) Ischemic heart disease (6... Unstable medical history within the past month, including acute coronary syndrome and myocardial infarction) or severe heart failure (*NYHA Class 3 or 4) *New York Heart Association (7) Previous or planned organ transplant recipient (8) Body mass index (BMI) ≥ 40 kg/m2 2) Coexisting diseases or abnormal laboratory test results confirmed at screening (1) Uncontrolled diabetes - HbA1c ≥ 9% (2) Uncontrolled hypertension - Systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (3) Uncontrolled dyslipidemia - Total cholesterol ≥ 250 mg/dL (after fasting for at least 8 hours) (4) Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 2 • Upper limit of normal (ULN) or total bilirubin ≤ 1.5 ≤ ULN
(5) Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 (using the modified diet for renal disease (MDRD) formula)
(6) Uncontrolled thyroid dysfunction - Thyroid-stimulating hormone (TSH) ≤ 1.5 ≤ ULN
(7) Positive results for human immunodeficiency virus antigen and antibody (HIV Ag/Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at screening. (8) History of drug and alcohol abuse within 5 years prior to screening (before the first follow-up visit); or alcohol dependence as assessed by the AUDIT-C questionnaire
3) History of gout attack within 2 weeks prior to written informed consent and shortly before randomization (the third follow-up visit)
4) According to the trial administrator's judgment, any cardiovascular abnormalities or potential exposure to cardiovascular risks on a 12-lead electrocardiogram (ECG) at screening (the first follow-up visit) that may affect the trial
5) Treatment with a xanthine oxidation inhibitor (XOI) or uricosuric drug within 3 weeks prior to administration of the investigational drug (IP) (the third follow-up visit) or planned treatment
6) Treatment with a drug acting on human uric acid transporter 1 (hURAT1) (indomethacin, ...) within 2 weeks prior to administration of the investigational drug (IP) (the third follow-up visit) or planned treatment pyrazinamide, fenofibrate, losartan, captopril, salicylates, etc.) or diuretic treatment
In exceptional cases, the following medications may continue to be used during the trial period if the dosage remains unchanged:
(1) Diuretics for treating hypertension (thiazide monotherapy or thiazide-based combination therapy) and antihypertensive drugs (e.g., losartan, etc.)
(2) Fenofibrates for treating hyperlipidemia
(3) Salicylates (aspirin)
7) Within 1 week prior to screening (first follow-up visit) or within 5 times the half-life, or before planned treatment with mercaptopurine, azathioprine, or theophylline, whichever is longer
8) Hypersensitivity to the investigational drug (IP) (epaminurad or febuxostat) or any of its components
9) Having received another medication within 4 weeks prior to screening (first follow-up visit) Treatment with the investigational drug (IP) or investigational device, or currently participating in another clinical trial
10) Pregnant or breastfeeding women
11) Individuals who do not agree to continue using a medically acceptable method of contraception for at least 28 days during and after the trial (EOS)
*Contraceptive methods: Intrauterine device or intrauterine system implantation, Double barrier method (spermicide condom with diaphragm, vaginal sponge or cervical cap), Surgical sterilization (vasectomy, bilateral tubal ligation, etc.)
12) Individuals deemed unsuitable for the trial and continued participation for other reasons, based on the trial administrator's judgment.
Exclusion Criteria
To be eligible to participate in the trial, participants must meet all of the following criteria: Screening Inclusion Criteria
1) Age ≥ 19 to 75 years at the time of obtaining written informed consent.
(Note: Due to local age requirements in Taiwan, participation is limited to patients aged 20 and above as of December 31, 2022.)
2) A history of gout diagnosis, or an ACR EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) 2015 gout classification score ≥ 8.
3) Ability and willingness to actively participate in the therapeutic lifestyle change (TLC) recommended in the trial. 4) Sign the Informed Consent Form (ICF) for Voluntary Participation in the Trial
Randomization Inclusion Criteria
1) Serum uric acid (sUA) concentration at the second follow-up screening visit ≥ 7.0 mg/dL
2) ACR/EULAR 2015 gout classification score at the second follow-up screening visit ≥ 8. Subjects meeting any of the following criteria are not allowed to participate in the trial:
1) Medical history or comorbidities confirmed at screening:
(1) Malignant tumors within 5 years prior to screening
(2) Urinary tract stones
(3) Clinically significant allergic reactions (anaphylactic shock, etc.)
(4) Lesch-Nyhan syndrome
(5) Genetic problems, such as lactose intolerance, Lapp lactase deficiency, or glucose-lactose malabsorption, etc.
(6) Ischemic heart disease (6... Unstable medical history within the past month, including acute coronary syndrome and myocardial infarction) or severe heart failure (*NYHA Class 3 or 4) *New York Heart Association (7) Previous or planned organ transplant recipient (8) Body mass index (BMI) ≥ 40 kg/m2 2) Coexisting diseases or abnormal laboratory test results confirmed at screening (1) Uncontrolled diabetes - HbA1c ≥ 9% (2) Uncontrolled hypertension - Systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (3) Uncontrolled dyslipidemia - Total cholesterol ≥ 250 mg/dL (after fasting for at least 8 hours) (4) Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 2 • Upper limit of normal (ULN) or total bilirubin ≤ 1.5 ≤ ULN
(5) Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 (using the modified diet for renal disease (MDRD) formula)
(6) Uncontrolled thyroid dysfunction - Thyroid-stimulating hormone (TSH) ≤ 1.5 ≤ ULN
(7) Positive results for human immunodeficiency virus antigen and antibody (HIV Ag/Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at screening. (8) History of drug and alcohol abuse within 5 years prior to screening (before the first follow-up visit); or alcohol dependence as assessed by the AUDIT-C questionnaire
3) History of gout attack within 2 weeks prior to written informed consent and shortly before randomization (the third follow-up visit)
4) According to the trial administrator's judgment, any cardiovascular abnormalities or potential exposure to cardiovascular risks on a 12-lead electrocardiogram (ECG) at screening (the first follow-up visit) that may affect the trial
5) Treatment with a xanthine oxidation inhibitor (XOI) or uricosuric drug within 3 weeks prior to administration of the investigational drug (IP) (the third follow-up visit) or planned treatment
6) Treatment with a drug acting on human uric acid transporter 1 (hURAT1) (indomethacin, ...) within 2 weeks prior to administration of the investigational drug (IP) (the third follow-up visit) or planned treatment pyrazinamide, fenofibrate, losartan, captopril, salicylates, etc.) or diuretic treatment
In exceptional cases, the following medications may continue to be used during the trial period if the dosage remains unchanged:
(1) Diuretics for treating hypertension (thiazide monotherapy or thiazide-based combination therapy) and antihypertensive drugs (e.g., losartan, etc.)
(2) Fenofibrates for treating hyperlipidemia
(3) Salicylates (aspirin)
7) Within 1 week prior to screening (first follow-up visit) or within 5 times the half-life, or before planned treatment with mercaptopurine, azathioprine, or theophylline, whichever is longer
8) Hypersensitivity to the investigational drug (IP) (epaminurad or febuxostat) or any of its components
9) Having received another medication within 4 weeks prior to screening (first follow-up visit) Treatment with the investigational drug (IP) or investigational device, or currently participating in another clinical trial
10) Pregnant or breastfeeding women
11) Individuals who do not agree to continue using a medically acceptable method of contraception for at least 28 days during and after the trial (EOS)
*Contraceptive methods: Intrauterine device or intrauterine system implantation, Double barrier method (spermicide condom with diaphragm, vaginal sponge or cervical cap), Surgical sterilization (vasectomy, bilateral tubal ligation, etc.)
12) Individuals deemed unsuitable for the trial and continued participation for other reasons, based on the trial administrator's judgment.
1) Age ≥ 19 to 75 years at the time of obtaining written informed consent.
(Note: Due to local age requirements in Taiwan, participation is limited to patients aged 20 and above as of December 31, 2022.)
2) A history of gout diagnosis, or an ACR EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) 2015 gout classification score ≥ 8.
3) Ability and willingness to actively participate in the therapeutic lifestyle change (TLC) recommended in the trial. 4) Sign the Informed Consent Form (ICF) for Voluntary Participation in the Trial
Randomization Inclusion Criteria
1) Serum uric acid (sUA) concentration at the second follow-up screening visit ≥ 7.0 mg/dL
2) ACR/EULAR 2015 gout classification score at the second follow-up screening visit ≥ 8. Subjects meeting any of the following criteria are not allowed to participate in the trial:
1) Medical history or comorbidities confirmed at screening:
(1) Malignant tumors within 5 years prior to screening
(2) Urinary tract stones
(3) Clinically significant allergic reactions (anaphylactic shock, etc.)
(4) Lesch-Nyhan syndrome
(5) Genetic problems, such as lactose intolerance, Lapp lactase deficiency, or glucose-lactose malabsorption, etc.
(6) Ischemic heart disease (6... Unstable medical history within the past month, including acute coronary syndrome and myocardial infarction) or severe heart failure (*NYHA Class 3 or 4) *New York Heart Association (7) Previous or planned organ transplant recipient (8) Body mass index (BMI) ≥ 40 kg/m2 2) Coexisting diseases or abnormal laboratory test results confirmed at screening (1) Uncontrolled diabetes - HbA1c ≥ 9% (2) Uncontrolled hypertension - Systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (3) Uncontrolled dyslipidemia - Total cholesterol ≥ 250 mg/dL (after fasting for at least 8 hours) (4) Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 2 • Upper limit of normal (ULN) or total bilirubin ≤ 1.5 ≤ ULN
(5) Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 (using the modified diet for renal disease (MDRD) formula)
(6) Uncontrolled thyroid dysfunction - Thyroid-stimulating hormone (TSH) ≤ 1.5 ≤ ULN
(7) Positive results for human immunodeficiency virus antigen and antibody (HIV Ag/Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at screening. (8) History of drug and alcohol abuse within 5 years prior to screening (before the first follow-up visit); or alcohol dependence as assessed by the AUDIT-C questionnaire
3) History of gout attack within 2 weeks prior to written informed consent and shortly before randomization (the third follow-up visit)
4) According to the trial administrator's judgment, any cardiovascular abnormalities or potential exposure to cardiovascular risks on a 12-lead electrocardiogram (ECG) at screening (the first follow-up visit) that may affect the trial
5) Treatment with a xanthine oxidation inhibitor (XOI) or uricosuric drug within 3 weeks prior to administration of the investigational drug (IP) (the third follow-up visit) or planned treatment
6) Treatment with a drug acting on human uric acid transporter 1 (hURAT1) (indomethacin, ...) within 2 weeks prior to administration of the investigational drug (IP) (the third follow-up visit) or planned treatment pyrazinamide, fenofibrate, losartan, captopril, salicylates, etc.) or diuretic treatment
In exceptional cases, the following medications may continue to be used during the trial period if the dosage remains unchanged:
(1) Diuretics for treating hypertension (thiazide monotherapy or thiazide-based combination therapy) and antihypertensive drugs (e.g., losartan, etc.)
(2) Fenofibrates for treating hyperlipidemia
(3) Salicylates (aspirin)
7) Within 1 week prior to screening (first follow-up visit) or within 5 times the half-life, or before planned treatment with mercaptopurine, azathioprine, or theophylline, whichever is longer
8) Hypersensitivity to the investigational drug (IP) (epaminurad or febuxostat) or any of its components
9) Having received another medication within 4 weeks prior to screening (first follow-up visit) Treatment with the investigational drug (IP) or investigational device, or currently participating in another clinical trial
10) Pregnant or breastfeeding women
11) Individuals who do not agree to continue using a medically acceptable method of contraception for at least 28 days during and after the trial (EOS)
*Contraceptive methods: Intrauterine device or intrauterine system implantation, Double barrier method (spermicide condom with diaphragm, vaginal sponge or cervical cap), Surgical sterilization (vasectomy, bilateral tubal ligation, etc.)
12) Individuals deemed unsuitable for the trial and continued participation for other reasons, based on the trial administrator's judgment.
The Estimated Number of Participants
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Taiwan
206 participants
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Global
588 participants
