Dotinurad versus Allopurinol for Tophaceous 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 study compares the uric acid–lowering effect of dotinurad with allopurinol in adults who have tophaceous gout. Eligible participants are 18–75 years old with gout for at least one year and at least one measurable tophus (5–30 mm), and must have serum uric acid ≥5.0 mg/dL at screening. Participants will receive either dotinurad or allopurinol and will have serum uric acid measured at Week 24 as the primary endpoint, with tophus measurements tracked at baseline and follow-up visits. The trial is being conducted at clinical sites in Alabama, including the Kirklin Clinic at UAB and community research centers.

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-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.

Where it's running

• The Kirklin Clinic of University of Alabama Birmingham Hospital
  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

+46 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.

• Dotinurad in gout patients who can’t tolerate XOI or failed uricase treatment

  This trial tests whether dotinurad can lower uric acid levels in adults with gout who can’t use certain standard medicines or have not benefited from uricase.

  Recruiting at 41 sites Phase 2 Crystalys Therapeutics · Birmingham, Alabama and 40 other locations · NCT07535034

• Dotinurad versus allopurinol for lowering uric acid in gout

  This trial tests whether dotinurad lowers blood uric acid more than allopurinol in adults with gout.

  Recruiting at 103 sites Phase 3 Crystalys Therapeutics · Birmingham, Alabama and 118 other locations · NCT07089875

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.