Not Yet RecruitingPhase 2

A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants

90 participantsStarted 2026-04

Plain-language summary

The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
✓. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following:
✓. sUA level \>6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).
✓. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
✓. 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 trial drug.

Exclusion criteria

✕. History of or presence of kidney stones within 1 year prior to Screening.
✕. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
✕. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
✕. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening.
✕. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.

What they're measuring

Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24

Timeframe: Week 24

Trial details

NCT IDNCT07535034

SponsorCrystalys Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Clinical Trial Lead

(858) 356-4740 ClinicalTrials@crystalystx.com

View on ClinicalTrials.gov More Gout trials