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Dotinurad versus Allopurinol for Tophaceous Gout

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous Gout

PHASE3 · Crystalys Therapeutics · NCT07089888

This trial will test whether dotinurad lowers serum uric acid more than allopurinol in adults with tophaceous gout over 24 weeks.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorCrystalys Therapeutics (industry)
Locations83 sites (Birmingham, Alabama and 82 other locations)
Trial IDNCT07089888 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with a diagnosis of gout for at least one year, at least one measurable tophus (5–30 mm), serum uric acid ≥5.0 mg/dL, and who meet pregnancy and contraception requirements are the intended participants.

Not a fit: People without measurable tophi, with serum uric acid below 5.0 mg/dL, outside the 18–75 age range, pregnant or breastfeeding, or unable to follow contraception requirements are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, dotinurad could provide better uric acid control that helps shrink tophi and reduce gout complications for some patients.

How similar studies have performed: Prior studies have shown dotinurad lowers serum uric acid in patients with hyperuricemia, but direct head-to-head data versus allopurinol specifically in tophaceous gout are limited.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 82 other locations

+33 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Tophaceous Gout, Dotinurad, Allopurinol, Hyperuricemia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.