A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

NCT05815901 | Completed Phase 3 DMC

• 1 other identifier: JW21301
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (4)

Epaminurad 6 mg

EXPERIMENTAL

\[Main study period\] 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; Drug: Epaminurad 9 mg placebo; Drug: Febuxostat 40 mg placebo; Drug: Febuxostat 80 mg placebo

Epaminurad 9 mg

EXPERIMENTAL

\[Main study period\] 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; Drug: Epaminurad 6 mg placebo; Drug: Febuxostat 40 mg placebo; Drug: Febuxostat 80 mg placebo

Febuxostat 40 mg

ACTIVE COMPARATOR

\[Main study period\] 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; Drug: Epaminurad 6 mg placebo; Drug: Epaminurad 9 mg placebo; Drug: Febuxostat 80 mg placebo

Febuxostat 80 mg

ACTIVE COMPARATOR

\[Main study period\] 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; Drug: Epaminurad 6 mg placebo; Drug: Epaminurad 9 mg placebo; Drug: Febuxostat 40 mg placebo

Interventions

Epaminurad 6 mg DRUG

Epaminurad 6 mg tablet

Epaminurad 6 mg

Epaminurad 9 mg DRUG

Epaminurad 9 mg tablet

Epaminurad 9 mg

Febuxostat 40 mg DRUG

Febuxostat 40 mg tablet

Febuxostat 40 mg

Febuxostat 80 mg DRUG

Febuxostat 80 mg tablet

Febuxostat 80 mg

Epaminurad 6 mg placebo DRUG

Placebo tablet

Epaminurad 9 mg; Febuxostat 40 mg; Febuxostat 80 mg

Epaminurad 9 mg placebo DRUG

Placebo tablet

Epaminurad 6 mg; Febuxostat 40 mg; Febuxostat 80 mg

Febuxostat 40 mg placebo DRUG

Placebo tablet

Epaminurad 6 mg; Epaminurad 9 mg; Febuxostat 80 mg

Febuxostat 80 mg placebo DRUG

Placebo tablet

Epaminurad 6 mg; Epaminurad 9 mg; Febuxostat 40 mg

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Gout

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Won Park, MD

  Inha University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 18, 2023
• Study Start: March 21, 2023
• Primary Completion: March 26, 2024
• Study Completion: April 23, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

KR (1)