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NCT07535034PHASE2Recruiting

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

Crystalys Therapeutics

Start Date

5/8/2026

Completion Date

8/1/2027

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 Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Dotinurad

OTHER

Placebo

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Conditions

Gout

Locations

Amicis Research Center

Granada Hills, California 91344

United States

Cohen Medical Center

Thousand Oaks, California 91360

United States

Solace Clinical Research

Tustin, California 92780

United States

Denver Arthritis Clinic - Lowry

Denver, Colorado 80230

United States

Omega Research Group

DeBary, Florida 32713

United States

Herco Medical and Research Center, Inc

Flagami, Florida 33126

United States

New Generation of Medical Research

Hialeah, Florida 33016

United States

Health Awareness, Inc.

Jupiter, Florida 33458

United States

Clinical Research of Central Florida

Lakeland, Florida 33805

United States

D&H Pompano Research Center, LLC

Margate, Florida 33063

United States

Panax Clinical Research

Miami, Florida 33014

United States

Anchor Medical Research

Miami, Florida 33176

United States

MD Medical Research

Oxon Hill, Maryland 20745

United States

Clinical Research Institute of Michigan

Saint Clair Shores, Michigan 48081

United States

Revival Research Institute

Sterling Heights, Michigan 48313

United States

Las Vegas Clinical Trials

Las Vegas, Nevada 89030

United States

Premier Health Research

Sparta, New Jersey 07871

United States

Ellipsis Research Group

Brooklyn, New York 11215

United States

Drug Trials America

Hartsdale, New York 10530

United States

Shelby Clinical Research

Shelby, North Carolina 28150

United States

Hometown Urgent Care and Research

Dayton, Ohio 45424

United States

Zenos Clinical Research

Dallas, Texas 75230

United States

Epic Medical Research

DeSoto, Texas 75115

United States

Pioneer Research Solutions

Houston, Texas 77479

United States

R&H Clinical Research - Westborough Drive

Katy, Texas 77449

United States

Southwest Rheumatology Research

Mesquite, Texas 75150

United States

Discovery Clinical Trials, LLC

San Antonio, Texas 78229

United States

DM Clinical Research

Tomball, Texas 77375

United States

Digestive Health Research of North Texas

Wichita Falls, Texas 76301

United States