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Dotinurad for Gout in XOI Intolerant/Uricase Failure Participants

This study is testing a drug called Dotinurad to see how well it lowers high uric acid levels in people with gout. You might be able to join if you are between 18 and 75 years old, have had gout for at least a year, and can't take other common gout medicines (Xanthine Oxidase Inhibitors, or XOI) or if those medicines haven't worked for you (uricase treatment failure). The study will compare Dotinurad to a placebo (an inactive pill) to see what percentage of participants achieve a serum uric acid (sUA) level below 6.0 mg/dL after 24 weeks. The study plans to enroll 90 participants, but the current recruitment status is unclear.

Study design
This is an interventional study that will compare Dotinurad to a placebo. It plans to enroll 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at Week 24, indicating follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07535034

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Crystalys Therapeutics
~90 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:DotinuradPlacebo

At a glance

Recruiting sites
29 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Measured over Week 24

Conditions

Gout

Explore related trials

GoutUric Acid

Where it's being run

29 sites across 11 states
Florida8
Texas8
California3
Michigan2
New York2
Colorado1
Maryland1
Nevada1

Who to contact

Clinical Trial Lead
[email protected]
1-858-379-2316
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.
Failed uricase treatment (eg, an sUA level \>6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment). 3. sUA level \>6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit). 4. 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. 5. 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.

What this trial measures

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