Ireland
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Recruiting Phase 2

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

NCT07535034 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-05-08
Last updated
2026-09-28

Condition(s) studied

Gout

Investigational drug(s) / intervention(s)

Dotinurad →Placebo

Dotinurad: Over-encapsulated tablets containing active drug substance administered orally.

Placebo: Capsules containing microcrystalline cellulose administered orally.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (41)

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

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07535034 on ClinicalTrials.gov ↗ ← All trials in the USA