Dotinurad versus allopurinol for lowering uric acid in gout

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares dotinurad and allopurinol in adults with gout and persistent hyperuricemia, with the main outcome being serum uric acid (sUA) level at Week 24. Participants must have had gout for at least one year, at least two flares in the prior 12 months, sUA ≥6.5 mg/dL, and be on a stable allopurinol dose for at least three months before enrollment. Enrolled adults receive either dotinurad or allopurinol and undergo scheduled visits and sUA measurements through Week 24 to compare urate-lowering effects. The trial is conducted at clinical sites in Alabama and Arizona.

Why it matters

Who can join: the full rules

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)-European Union 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 the participant or documented in the participant's medical records).
4. Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment as documented in the participant's medical history) up to 600 mg/day for at least 3 months prior to Screening and remain 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 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.
7. 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 both colchicine and nonsteroidal anti-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 B Surface Antigen, or Hepatitis C antibodies during Screening.
6. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• G&L Research
  Foley, Alabama, United States Recruiting
• Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
  Gilbert, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
  Glendale, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
  Mesa, Arizona, United States Recruiting
• Del Sol Research Management - Tucson East
  Tucson, Arizona, United States Recruiting

+69 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trial Lead
• Email: ClinicalTrials@crystalystx.com
• Phone: 1-858-379-2316

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.