Clinical trial NCT05815901: A Therapeutic Confirmatory Study of Epaminurad Versus 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gout
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 588
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of subjects with sUA <6 mg/dL post-dose at each visit
timeFrame: up to Week 24
measure: Proportion of subjects with sUA <5 mg/dL at the last 3 time points
timeFrame: Week 16, 20, 24
measure: Proportion of subjects with sUA <5 mg/dL post-dose at each visit
timeFrame: up to Week 24
measure: Change from baseline in sUA (mg/dL) at each visit
timeFrame: up to Week 24
measure: Percent change from baseline in sUA at each visit
timeFrame: up to Week 24
measure: Incidence of gout flare post-dose up to Week 24
timeFrame: up to Week 24
measure: Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24
timeFrame: up to Week 24
measure: Adverse events
timeFrame: up to Week 52
measure: Number of subjects with clinical significant results of Laboratory tests
timeFrame: up to Week 52
measure: Number of subjects with clinical significant results of Vital signs
timeFrame: up to Week 52
measure: Number of subjects with clinical significant results of Electrocardiogram
timeFrame: up to Week 52
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Won Park, MD
role: STUDY_CHAIR
References: