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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-finding Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of URC102 in Patient With Gout

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.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: arm 0; Drug: arm 1; Drug: arm 2; Drug: arm 3; Drug: arm 4

Detailed Description

Placebo-controlled, randomized, double-blind, multicenter, phase 2 clinical trial.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 06725
    • JW Pharmaceutical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Screening Inclusion Criteria The subjects must meet all the following criteria to be eligible for articipation in this study.

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

• Randomization Inclusion Criterion. Subjects who meet the screening inclusion criteria will be randomly assigned to the following criteria.

  1. sUA ≥ 7.0 mg/dL at Visit 2

     Exclusion Criteria:

  1. 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)

  2. 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
  3. 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
  4. Patients who have received or plan to receive any XOI or uricosuric agents within 3 weeks prior to study treatment
  5. 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)
  6. 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
  7. HIV Ag/Ab, HBs Ag or HCV Ab positive at screening
  8. Subjects who have known hypersensitivity or allergy to IPs (URC102 or febuxostat) or any components in their formulations
  9. Subjects who have childbearing or nursing

  10. Subjects who agree to use methods of birth control* during the study period and for up to 7 days after the final administration of the IP

      * Methods of birth control: ① intrauterine device or birth control implant, ② dual protection (condom with spermicide and contraceptive diaphragm or contraceptive sponge or cervical cap ③ surgical sterilization (vasectomy or tubal ligation or etc.)

  11. Subjects who have been administered any other IP or investigational device by participating in other studieswithin 4 weeks or within more than 5 times of its halflife prior to the Visit 1
  12. Subjects who have a history of drug or alcohol abuse within 5 years prior to the Visit 1
  13. Subjects who have any other reason that may affect the study or those who are judged by the investigator to be ineligible for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; maintain the initial dose, without increasing the dose.	Drug: arm 0; placebo group
ACTIVE_COMPARATOR: URC102 3mg; Administer 3 mg of URC102 for 12 weeks	Drug: arm 1; 3 mg of the URC102 group
ACTIVE_COMPARATOR: URC102 6mg; Administer 3 mg of URC102 for 1 week and 6 mg of URC102 for 11 Weeks.	Drug: arm 2; 6 mg of the URC102 group
ACTIVE_COMPARATOR: URC102 9mg; 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; 9 mg of the URC102 group
OTHER: Febuxostat 80 mg; maintain the initial dose, without increasing the dose.	Drug: arm 4; Febuxostat 80 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum uric acid response rate (< 6.0 mg/dL) at week 4 after the IP administration.	Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
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
serum uric acid response rate(< 5.0 mg/dL) at week 8 and week 12 after the IP administration	Week 8, Week 12
Percent Change in Serum Uric Acid from Baseline to week 8 and week 12	Week 8, Week 12
Change in Serum Uric Acid at week 8 and 12 from Baseline	Week 8, Week 12
The Incidence rate of gout attack from baseline to week 8 and 12	Week 8, Week 12

Collaborators and Investigators

• Sponsor: JW Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2019
• Primary Completion (ACTUAL): September 4, 2020
• Study Completion (ACTUAL): November 29, 2020

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (ACTUAL): March 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: JWP-URC-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No