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GoutPhase 2URC102NCT04804111

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

A Phase 2 study testing arm 0, arm 1 and arm 2 in people with Gout, run by JW Pharmaceutical at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 69 years
Conditions the study is for
Gout
What is being tested?
arm 0, arm 1 and arm 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
2 sitesSouth Korea
Study dates
21 Jan 2019to 29 Nov 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Screening Inclusion Criteria The subjects must meet all the following criteria to be eligible for articipation in this study.
  • 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
  • Randomization Inclusion Criterion. Subjects who meet the screening inclusion criteria will be randomly assigned to the following criteria.
  • sUA ≥ 7.0 mg/dL at Visit 2

Who cannot join

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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
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  • 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
  • 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.)
  • 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
  • Subjects who have a history of drug or alcohol abuse within 5 years prior to the Visit 1
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • JW Pharmaceutical

    Seoul, 06725

  • Chung-Ang University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the detailed description

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

Conditions
Gout
Being tested
arm 0, arm 1, arm 2, arm 3, arm 4
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arm 0Drug

    placebo group

  • arm 1Drug

    3 mg of the URC102 group

  • arm 2Drug

    6 mg of the URC102 group

  • arm 3Drug

    9 mg of the URC102 group

  • arm 4Drug

    Febuxostat 80 mg

Study groups in NCT04804111
Study groupRoleWhat they receive
PlaceboPlacebo comparatormaintain the initial dose, without increasing the dose.
Receives: Drug: arm 0
URC102 3mgActive comparatorAdminister 3 mg of URC102 for 12 weeks
Receives: Drug: arm 1
URC102 6mgActive comparatorAdminister 3 mg of URC102 for 1 week and 6 mg of URC102 for 11 Weeks.
Receives: Drug: arm 2
URC102 9mgActive comparatorAdminister 3 mg of URC102 for 1 week and 6 mg of URC102 for 1 Weeks, maintain 9 mg of URC102 dose
Receives: Drug: arm 3
Febuxostat 80 mgOthermaintain the initial dose, without increasing the dose.
Receives: Drug: arm 4

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 4

Secondary outcomes (9)

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

    Measured: Week 4

  2. Percent Change in Serum Uric Acid from Baseline to week 4

    Measured: Week 4

  3. Change in Serum Uric Acid at week 4 from Baseline

    Measured: Week 4

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

    Measured: week 4

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

    Measured: Week 8, Week 12

  6. serum uric acid response rate(< 5.0 mg/dL) at week 8 and week 12 after the IP administration

    Measured: Week 8, Week 12

  7. Percent Change in Serum Uric Acid from Baseline to week 8 and week 12

    Measured: Week 8, Week 12

  8. Change in Serum Uric Acid at week 8 and 12 from Baseline

    Measured: Week 8, Week 12

  9. The Incidence rate of gout attack from baseline to week 8 and 12

    Measured: Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start21 Jan 2019
  3. Primary completion4 Sep 2020
  4. Study completion29 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04804111
Sponsor's protocol ID
JWP-URC-203
Acronym
URC102
Status last verified
Nov 2020
First submitted
15 Nov 2020
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40420308

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing arm 0, arm 1 and arm 2 in people with Gout, run by JW Pharmaceutical at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum uric acid response rate (< 6.0 mg/dL) at week 4 after the IP administration. (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04804111, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

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