A Study of Dotinurad Versus Allopurinol in Participants With Gout

Inclusion Criteria:

1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.

2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-EuropeanUnion League Against Rheumatism (EULAR) criteria for at least 1 year.

3. Had at least 2 gout flares in the 12 months prior to Screening (reported by theparticipant or documented in the participant's medical records).

4. Participant must be on a stable background allopurinol dose of ≥300 mg/day (200mg/day for those with moderate renal impairment as documented in the participant'smedical history) up to 600 mg/day for at least 3 months prior to Screening andremain on their dosing regimen until Day 1.

5. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).

6. Female participants of childbearing potential must have a negative serum pregnancytest at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), anegative urine pregnancy test on Day 1, and must not be breastfeeding.

7. Fertile male participants and female participants of childbearing potential must bewilling to completely abstain from heterosexual sex or agree to use acceptablecontraception from the time of signing informed consent through 30 days after thelast dose of study drug.

Exclusion Criteria:

1. History of or presence of kidney stones within 1 year prior to Screening.

2. History of or presence of malignancy in the last 5 years other than treatedcutaneous basal or squamous cell carcinoma.

3. Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidalanti-inflammatory drugs.

4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1,or a recent history of alcohol abuse.

5. Known history of or positive results for human immunodeficiency virus, Hepatitis BSurface Antigen, or Hepatitis C antibodies during Screening.

6. Current or historical evidence of any clinically significant disease or conditionthat, in the opinion of the Investigator, may compromise participant safety or studycompliance or may confound interpretation of study results.