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

RecruitingPhase 2

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

Who can join

Ages 18 to 75 · All sexes

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.

About the study

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.

What is being tested

Sponsor: Crystalys Therapeutics · Participants: 90 · Started: May 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07535034

Locations in the U.S.

AlabamaThe Kirklin Clinic of UAB Hospital, Birmingham
ArizonaArizona Arthritis & Rheumatology Research, PLLC, Phoenix
AARA Clinical Research-SE Tucson, Tucson
CaliforniaAmicis Research Center, Granada Hills
Cohen Medical Center, Thousand Oaks
Solace Clinical Research, Tustin
ColoradoDenver Arthritis Clinic - Lowry, Denver
FloridaOmega Research Group, DeBary
Herco Medical and Research Center, Inc, Flagami
New Generation of Medical Research, Hialeah
Health Awareness, Inc., Jupiter
Clinical Research of Central Florida, Lakeland
D&H Pompano Research Center, LLC, Margate
Anchor Medical Research, Miami
Panax Clinical Research, Miami
GeorgiaSouthwest Atlanta Internal Medicine, Atlanta
IllinoisGreat Lakes Clinical Trials, Chicago
KentuckyResearch Group of Lexington, LLC, Lexington
MarylandMD Medical Research, Oxon Hill
AARA Clinical Research-Arthritis and Rheumatism Associates, Rockville
MichiganClinical Research Institute of Michigan, Saint Clair Shores
Revival Research Institute, Sterling Heights
Oakland Medical Research Center, Troy
NebraskaVelocity Clinical Research, Norfolk
NevadaLas Vegas Clinical Trials, Las Vegas
New JerseyPremier Health Research, Sparta
New YorkEllipsis Research Group, Brooklyn
Drug Trials America, Hartsdale
North CarolinaDJL Clinical Research, Charlotte
Shelby Clinical Research, Shelby
OhioHometown Urgent Care and Research, Dayton
TexasAmarillo Premier Research, Amarillo
Zenos Clinical Research, Dallas
Epic Medical Research, DeSoto
Pioneer Research Solutions, Houston
R&H Clinical Research - Westborough Drive, Katy
Southwest Rheumatology Research, Mesquite
Discovery Clinical Trials, LLC, San Antonio
DM Clinical Research, Tomball
Velocity Clinical Research (Impact Research Institute), Waco
Digestive Health Research of North Texas, Wichita Falls

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.