Clinical trial

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

NCT05815901

Name

JW21301

Description

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

Trial arms

Trial start

2023-03-14

Estimated PCD

2025-08-01

Trial end

2025-08-01

Status

Recruiting

Phase

Early phase I

Treatment

Epaminurad 6 mg

Epaminurad 6 mg tablet

Arms:

Epaminurad 6 mg

Epaminurad 9 mg

Epaminurad 9 mg tablet

Arms:

Epaminurad 9 mg

Febuxostat 40 mg

Febuxostat 40 mg tablet

Arms:

Febuxostat 40 mg

Febuxostat 80 mg

Febuxostat 80 mg tablet

Arms:

Febuxostat 80 mg

Epaminurad 6 mg placebo

Placebo tablet

Arms:

Epaminurad 9 mg, Febuxostat 40 mg, Febuxostat 80 mg

Epaminurad 9 mg placebo

Placebo tablet

Arms:

Epaminurad 6 mg, Febuxostat 40 mg, Febuxostat 80 mg

Febuxostat 40 mg placebo

Placebo tablet

Arms:

Epaminurad 6 mg, Epaminurad 9 mg, Febuxostat 80 mg

Febuxostat 80 mg placebo

Placebo tablet

Arms:

Epaminurad 6 mg, Epaminurad 9 mg, Febuxostat 40 mg

Size

588

Primary endpoint

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

Week 24

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 588, 'type': 'ESTIMATED'}}

Updated at

2023-04-18

1 organization

2 products

1 indication

Product

Indication

Organization

Product