NCT07535034From ClinicalTrials.govRecruiting

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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment

Gout

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Crystalys Therapeutics
Enrolment target: 90
Started: 8 May 2026
Main results due: July 2027
Study sites: 41
Registry updated: 28 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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 (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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(41)

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
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
Recruiting
Omega Research Group
DeBary, Florida, United States
Recruiting
Herco Medical and Research Center, Inc
Flagami, Florida, United States
Recruiting
New Generation of Medical Research
Hialeah, Florida, United States
Recruiting
Health Awareness, Inc.
Jupiter, Florida, United States
Recruiting
Clinical Research of Central Florida
Lakeland, Florida, United States
Recruiting
D&H Pompano Research Center, LLC
Margate, Florida, United States
Recruiting
Panax Clinical Research
Miami, Florida, United States
Recruiting
Anchor Medical Research
Miami, Florida, United States
Recruiting
Southwest Atlanta Internal Medicine
Atlanta, Georgia, United States
Recruiting
Great Lakes Clinical Trials
Chicago, Illinois, United States
Recruiting
Research Group of Lexington, LLC
Lexington, Kentucky, United States
Recruiting
MD Medical Research
Oxon Hill, Maryland, United States
Recruiting
AARA Clinical Research-Arthritis and Rheumatism Associates
Rockville, Maryland, United States
Recruiting
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, United States
Recruiting
Revival Research Institute
Sterling Heights, Michigan, United States
Recruiting
Oakland Medical Research Center
Troy, Michigan, United States
Recruiting
Velocity Clinical Research
Norfolk, Nebraska, United States
Recruiting
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
Recruiting
Premier Health Research
Sparta, New Jersey, United States
Recruiting
Ellipsis Research Group
Brooklyn, New York, United States
Recruiting
Drug Trials America
Hartsdale, New York, United States
Recruiting
DJL Clinical Research
Charlotte, North Carolina, United States
Recruiting
Shelby Clinical Research
Shelby, North Carolina, United States
Recruiting
Hometown Urgent Care and Research
Dayton, Ohio, United States
Recruiting
Amarillo Premier Research
Amarillo, Texas, United States
Recruiting
Zenos Clinical Research
Dallas, Texas, United States
Recruiting
Epic Medical Research
DeSoto, Texas, United States
Recruiting
Pioneer Research Solutions
Houston, Texas, United States
Recruiting
R&H Clinical Research - Westborough Drive
Katy, Texas, United States
Recruiting
Southwest Rheumatology Research
Mesquite, Texas, United States
Recruiting
Discovery Clinical Trials, LLC
San Antonio, Texas, United States
Recruiting
DM Clinical Research
Tomball, Texas, United States
Recruiting
Velocity Clinical Research (Impact Research Institute)
Waco, Texas, United States
Recruiting
Digestive Health Research of North Texas
Wichita Falls, Texas, United States
Recruiting

Showing 41 of 41 sites. 41 of the 41 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07535034. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me