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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Gout

In brief

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.

Key facts

Study ID

NCT07535034

Run by

Crystalys Therapeutics

People needed

90

Starts

2026-05-08

Expected to finish

2027-08-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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).
• 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.

You may not qualify if…

• 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.

Where it is running

• Amicis Research Center — Granada Hills, California, United States (enrolling)
• Cohen Medical Center — Thousand Oaks, California, United States (enrolling)
• Solace Clinical Research — Tustin, California, United States (enrolling)
• Denver Arthritis Clinic - Lowry — Denver, Colorado, United States (enrolling)
• Omega Research Group — DeBary, Florida, United States (enrolling)
• Herco Medical and Research Center, Inc — Flagami, Florida, United States (enrolling)
• New Generation of Medical Research — Hialeah, Florida, United States (enrolling)
• Health Awareness, Inc. — Jupiter, Florida, United States (enrolling)
• Clinical Research of Central Florida — Lakeland, Florida, United States (enrolling)
• D&H Pompano Research Center, LLC — Margate, Florida, United States (enrolling)
• Panax Clinical Research — Miami, Florida, United States (enrolling)
• Anchor Medical Research — Miami, Florida, United States (enrolling)
• MD Medical Research — Oxon Hill, Maryland, United States (enrolling)
• Clinical Research Institute of Michigan — Saint Clair Shores, Michigan, United States (enrolling)
• Revival Research Institute — Sterling Heights, Michigan, United States (enrolling)
• Las Vegas Clinical Trials — Las Vegas, Nevada, United States (enrolling)
• Premier Health Research — Sparta, New Jersey, United States (enrolling)
• Ellipsis Research Group — Brooklyn, New York, United States (enrolling)
• Drug Trials America — Hartsdale, New York, United States (enrolling)
• Shelby Clinical Research — Shelby, North Carolina, United States (enrolling)
• Hometown Urgent Care and Research — Dayton, Ohio, United States (enrolling)
• Zenos Clinical Research — Dallas, Texas, United States (enrolling)
• Epic Medical Research — DeSoto, Texas, United States (enrolling)
• Pioneer Research Solutions — Houston, Texas, United States (enrolling)
• R&H Clinical Research - Westborough Drive — Katy, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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