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

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 is a Phase 2 interventional study evaluating dotinurad versus placebo in gout patients who are intolerant or nonresponsive to xanthine oxidase inhibitors or uricase. The study will measure changes in serum uric acid at Week 24 to determine efficacy. Eligible participants are adults 18–75 with stable gout and specific intolerance or failure histories, with defined uric acid ranges at screening. The trial is conducted at multiple specialty sites in the United States with Crystalys Therapeutics as lead sponsor.

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 (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).
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.

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. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
4. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening.
5. 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's running

• The Kirklin Clinic of UAB Hospital
  Birmingham, Alabama, United States Recruiting
• Arizona Arthritis & Rheumatology Research, PLLC
  Phoenix, Arizona, United States Recruiting
• AARA Clinical Research-SE Tucson
  Tucson, Arizona, United States Recruiting
• Amicis Research Center
  Granada Hills, California, United States Recruiting
• Cohen Medical Center
  Thousand Oaks, California, United States Recruiting
• Solace Clinical Research
  Tustin, California, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Lead
• Email: ClinicalTrials@crystalystx.com
• Phone: 1-858-379-2316

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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.