A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

Launched by CRYSTALYS THERAPEUTICS · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called dotinurad to see how well it lowers uric acid levels in adults with tophaceous gout, a type of gout where lumps called tophi form around the joints. The study will compare dotinurad to allopurinol, a commonly used gout treatment, to find out which one works better after 24 weeks.

Adults between 18 and 75 years old who have had gout for at least a year and have at least one tophus (a lump caused by uric acid buildup) on their hands, wrists, feet, or ankles may be eligible to join. Participants will also need to have certain uric acid levels and, if they can have children, must agree to use birth control during the study. People with recent kidney stones, certain infections, or allergies to the study medicines will not be able to participate. If you join, you can expect regular check-ups to measure uric acid and monitor your health over about six months. This study is not yet open for enrolling participants.

Gender

ALL

Eligibility criteria

• • 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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
• • 3. Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter.
• • 4. sUA level ≥5.0 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
• • 5. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
• • 6. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last 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 treated cutaneous basal or squamous cell carcinoma.
• • 3. Hypersensitivity or intolerance to dotinurad or to colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs).
• • 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 (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.