Study of of URC102 to Assess the Efficacy and Safety in Gout Patients

NCT04804111 | Completed Phase 2

• 1 other identifier: JWP-URC-203
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 2

Brief Summary

To confirm the safety and efficacy (dose response and optimal dose according to the serum uric acid response rate) of URC102 when orally-administered to patients with gout and gout-related hyperuricemia in comparison with placebo. Therapeutic dose-finding study, Placebo-controlled, randomized, double-blind, multicenter, phase 2 clinical trial.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Serum uric acid response rate (< 6.0 mg/dL) at week 4 after the IP administration.

  Week 4

Secondary Outcomes (9)

• Serum uric acid response rate (< 5.0 mg/dL) at week 4 after the IP administration.

  Week 4

• Percent Change in Serum Uric Acid from Baseline to week 4

  Week 4

• Change in Serum Uric Acid at week 4 from Baseline

  Week 4

• The Incidence rate of gout attack from baseline to week 4

  week 4

• Serum uric acid response rate(< 6.0 mg/dL) at week 8 and week 12 after the IP administration

  Week 8, Week 12

Study Arms (5)

Placebo

PLACEBO COMPARATOR

maintain the initial dose, without increasing the dose.

Drug: arm 0

URC102 3mg

ACTIVE COMPARATOR

Administer 3 mg of URC102 for 12 weeks

Drug: arm 1

URC102 6mg

ACTIVE COMPARATOR

Administer 3 mg of URC102 for 1 week and 6 mg of URC102 for 11 Weeks.

Drug: arm 2

URC102 9mg

ACTIVE COMPARATOR

Administer 3 mg of URC102 for 1 week and 6 mg of URC102 for 1 Weeks, maintain 9 mg of URC102 dose

Drug: arm 3

Febuxostat 80 mg

OTHER

maintain the initial dose, without increasing the dose.

Drug: arm 4

Interventions

arm 0 DRUG

placebo group

Placebo

arm 1 DRUG

3 mg of the URC102 group

URC102 3mg

arm 2 DRUG

6 mg of the URC102 group

URC102 6mg

arm 3 DRUG

9 mg of the URC102 group

URC102 9mg

arm 4 DRUG

Febuxostat 80 mg

Febuxostat 80 mg

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are aged ≥19 and \<70 years at the time of providing written informed consent
• Subjects who are diagnosed with gout according to American College of Rheumatology (1977) criteria for the classification of acute arthritis of primary gout.
• Subjects who have the ability and willingness to actively conduct TLC recommended in this study
• Subjects who provided written informed consent to voluntarily participate in the study
• sUA ≥ 7.0 mg/dL at Visit 2

You may not qualify if:

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• Subjects who have medical history or comorbidity as follow; (1) Active malignancy or history of malignancy within the past 5 years at the time of screening (2) Urolithiasis (3) Clinically important allergic disease (anaphylactic shock, etc.) (4) Lesch-Nyhan syndrome (5) Hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (6) Ischemic heart diseases or congestive heart failure (7) Organ transplantation (recipient or scheduled to receipt)
• Subjects who have comorbidity or abnormality of lab results as follows; (1) Uncontrolled diabetes mellitus with drug therapy
• HbA1c ≥ 9% or
• Fasting plasma glucose (FPG) ≥160 mg/dL (2) Uncontrolled hypertension with treatment
• Systolic blood pressure (SBP) ≥180 mmHg or
• Diastolic blood pressure (DBP) ≥ 110 mmHg (3) Uncontrolled dyslipidemia with treatment
• Total cholesterol ≥ 250 mg/dL (at least 8 hours of fasting) (4) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 X upper limit of normal (ULN) or Total bilirubin ≥ 1.5 X ULN (5) eGFR\* \< 60 mL/min/1.73m2 \* eGFR (MDRD equation) GFR(ml/min/1.73m2) = 186 × (SCr)-1.154 × (age)-0.203 × (0.742 if female) × (1.210 if African American) (6) Uncontrolled thyroid function with treatment (thyroid-stimulating hormone (TSH) ≥ 1.5 X UNL
• Subjects who are judged by the investigator to have a clinical cardiovascular disease that may affect the study based on the 12-lead ECG obtained at screening or those suspected to be at such risk
• Patients who have received or plan to receive any XOI or uricosuric agents within 3 weeks prior to study treatment
• Patients who have received or plan to receive diuretics or any medication action on human Uric Acid Transporter 1(hURAT1) such as indomethacin, pyrazinamide, fenofibrate, atorvastatin, amlodipine, losartan, captopril, enalapril, salicylates etc. within 2 weeks prior to study treatment However, those who have been on stable doses as below are allowed to participate in the study, if the administration method and dosage remain the same during the study period (1) Diuretics (thiazide only or thiazide-based combination, etc.) and antihypertensive agents (losartan etc.) used for the treatment of hypertension (2) Fenofibrate or lipid lowering drugs (atorvastatin) used for hyperlipidemia (3) Salicylates (aspirin)
• Patients who have been administered or plan to administer Mercaptopurine, Azathioprine, Theophyline within 1 week or within more than 5 times of its half-life prior to the Visit 1
• HIV Ag/Ab, HBs Ag or HCV Ab positive at screening
• Subjects who have known hypersensitivity or allergy to IPs (URC102 or febuxostat) or any components in their formulations
• Subjects who have childbearing or nursing

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (2)

JW Pharmaceutical

Seoul, 06725, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Jun JB, Lee HS, Kim SH, Lee SG, Lim DH, Kim J, Park YB, Lim MJ, Hong SJ, Choi HJ, Lee SS, Kim HA, Hwang J, Suh CH, Han S, Choe JY, Yoo WH, Song JS. Efficacy and safety of epaminurad, a potent hURAT1 inhibitor, in patients with gout: a randomized, placebo-controlled, dose-finding study. Arthritis Res Ther. 2025 May 26;27(1):113. doi: 10.1186/s13075-025-03577-w.

  PMID: 40420308 DERIVED

MeSH Terms

Conditions

Gout

Interventions

DMAC2L protein, human

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: March 18, 2021
• Study Start: January 21, 2019
• Primary Completion: September 4, 2020
• Study Completion: November 29, 2020
• Last Updated: March 18, 2021

Record last verified: 2020-11

Locations

KR (2)