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RecruitingPhase 2

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

Crystalys Therapeutics · NCT07535034

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
90
US sites recruiting
41
Study start
May 8, 2026
Record last updated
September 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Dotinurad; Placebo

Conditions: Gout

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
  • 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).
  • sUA level >6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).
  • 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.
  • 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

  • History of or presence of kidney stones within 1 year prior to Screening.
  • History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
  • Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
  • Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening.
  • 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.

Recruiting US locations

  • The Kirklin Clinic of UAB Hospital

    Birmingham, AL 35233

    Site contact: Kenneth Saag, MD

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, AZ 85032

    Site contact: Nita Kumar, MD

  • AARA Clinical Research-SE Tucson

    Tucson, AZ 85748

    Site contact: Romy Cabacungan, MD

  • Amicis Research Center

    Granada Hills, CA 91344

    Site contact: Pascal Dabel, MD

  • Cohen Medical Center

    Thousand Oaks, CA 91360

    Site contact: Shariar Cohen-Gadol, MD

  • Solace Clinical Research

    Tustin, CA 92780

    Site contact: Roger Kornu, MD

  • Denver Arthritis Clinic - Lowry

    Denver, CO 80230

    Site contact: Christopher Antolini, MD

  • Omega Research Group

    DeBary, FL 32713

    Site contact: Kwabena Ayesu, MD

  • Herco Medical and Research Center, Inc

    Flagami, FL 33126

    Site contact: Eddy Capote, MD

  • New Generation of Medical Research

    Hialeah, FL 33016

    Site contact: Karelia Ruiz, MD

  • Health Awareness, Inc.

    Jupiter, FL 33458

    Site contact: Ronald Surowitz, MD

  • Clinical Research of Central Florida

    Lakeland, FL 33805

    Site contact: Michael Gimness, MD

  • D&H Pompano Research Center, LLC

    Margate, FL 33063

    Site contact: Mazyar Rouhani, MD

  • Panax Clinical Research

    Miami, FL 33014

    Site contact: Robert Perry, MD

  • Anchor Medical Research

    Miami, FL 33176

    Site contact: Juvenal Martinez, MD

  • Southwest Atlanta Internal Medicine

    Atlanta, GA 30331

    Site contact: Tamara Brown, MD

  • Great Lakes Clinical Trials

    Chicago, IL 60640

    Site contact: Manish Jain, MD

  • Research Group of Lexington, LLC

    Lexington, KY 40503

    Site contact: Justin Arambasick, MD

  • MD Medical Research

    Oxon Hill, MD 20745

    Site contact: Stephen Ong, MD

  • AARA Clinical Research-Arthritis and Rheumatism Associates

    Rockville, MD 20850

    Site contact: Evan Siegel, MD

  • Clinical Research Institute of Michigan

    Saint Clair Shores, MI 48081

    Site contact: Amar Majjhoo, MD

  • Revival Research Institute

    Sterling Heights, MI 48313

    Site contact: Syed Husain, MD

  • Oakland Medical Research Center

    Troy, MI 48085

    Site contact: Jay Sandberg, MD

  • Velocity Clinical Research

    Norfolk, NE 68701

    Site contact: Charles Harper, MD

  • Las Vegas Clinical Trials

    Las Vegas, NV 89030

    Site contact: Alton Walters, MD

  • Premier Health Research

    Sparta, NJ 07871

    Site contact: Haroon Sarwar, MD

  • Ellipsis Research Group

    Brooklyn, NY 11215

    Site contact: Jorge Serje, MD

  • Drug Trials America

    Hartsdale, NY 10530

    Site contact: Michael Gerdis, MD

  • DJL Clinical Research

    Charlotte, NC 28211

    Site contact: Emily Jane Herron Box, MD

  • Shelby Clinical Research

    Shelby, NC 28150

    Site contact: Christian Martin, MD

  • Hometown Urgent Care and Research

    Dayton, OH 45424

    Site contact: Carol Bland, MD

  • Amarillo Premier Research

    Amarillo, TX 79124

    Site contact: Susan Neese, MD

  • Zenos Clinical Research

    Dallas, TX 75230

    Site contact: Bachar Elsaadi, MD

  • Epic Medical Research

    DeSoto, TX 75115

    Site contact: Haresh Boghara, MD

  • Pioneer Research Solutions

    Houston, TX 77479

    Site contact: Francisco Velazquez, MD

  • R&H Clinical Research - Westborough Drive

    Katy, TX 77449

    Site contact: Maryam Khawari, MD

  • Southwest Rheumatology Research

    Mesquite, TX 75150

    Site contact: Atul Singhal, MD

  • Discovery Clinical Trials, LLC

    San Antonio, TX 78229

    Site contact: Abha Gyani, MD

  • DM Clinical Research

    Tomball, TX 77375

    Site contact: Shaikh Ali, MD

  • Velocity Clinical Research (Impact Research Institute)

    Waco, TX 76710

    Site contact: Hing-Sheung Fung, MD

  • Digestive Health Research of North Texas

    Wichita Falls, TX 76301

    Site contact: Vanya Wagler, MD

Study contacts (from the official record)

  • Clinical Trial Lead · 1-858-379-2316 · ClinicalTrials@crystalystx.com
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A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI)… (NCT07535034) | Bored Studies