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GoutPhase 2NCT07535034

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

A Phase 2 study testing Dotinurad in people with Gout, run by Crystalys Therapeutics at 41 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gout
What is being tested?
Dotinurad
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
41 sitesUnited States
Study dates
8 May 2026to Aug 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

41 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Lead contact

1-858-379-2316

ClinicalTrials@crystalystx.com

41 sites in 1 country

United States41 sites, 41 recruiting

  • Amarillo Premier Research

    Amarillo, Texas, 79124

    Susan Neese, MD

    Recruiting

  • Southwest Atlanta Internal Medicine

    Atlanta, Georgia, 30331

    Tamara Brown, MD

    Recruiting

  • The Kirklin Clinic of UAB Hospital

    Birmingham, Alabama, 35233

    Kenneth Saag, MD

    Recruiting

  • Ellipsis Research Group

    Brooklyn, New York, 11215

    Jorge Serje, MD

    Recruiting

  • DJL Clinical Research

    Charlotte, North Carolina, 28211

    Emily Jane Herron Box, MD

    Recruiting

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

    Manish Jain, MD

    Recruiting

  • Zenos Clinical Research

    Dallas, Texas, 75230

    Bachar Elsaadi, MD

    Recruiting

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45424

    Carol Bland, MD

    Recruiting

  • Omega Research Group

    DeBary, Florida, 32713

    Kwabena Ayesu, MD

    Recruiting

  • Denver Arthritis Clinic - Lowry

    Denver, Colorado, 80230

    Christopher Antolini, MD

    Recruiting

  • Epic Medical Research

    DeSoto, Texas, 75115

    Haresh Boghara, MD

    Recruiting

  • Herco Medical and Research Center, Inc

    Flagami, Florida, 33126

    Eddy Capote, MD

    Recruiting

  • Amicis Research Center

    Granada Hills, California, 91344

    Pascal Dabel, MD

    Recruiting

  • Drug Trials America

    Hartsdale, New York, 10530

    Michael Gerdis, MD

    Recruiting

  • New Generation of Medical Research

    Hialeah, Florida, 33016

    Karelia Ruiz, MD

    Recruiting

  • Pioneer Research Solutions

    Houston, Texas, 77479

    Francisco Velazquez, MD

    Recruiting

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

    Ronald Surowitz, MD

    Recruiting

  • R&H Clinical Research - Westborough Drive

    Katy, Texas, 77449

    Maryam Khawari, MD

    Recruiting

  • Clinical Research of Central Florida

    Lakeland, Florida, 33805

    Michael Gimness, MD

    Recruiting

  • Las Vegas Clinical Trials

    Las Vegas, Nevada, 89030

    Alton Walters, MD

    Recruiting

  • Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

    Justin Arambasick, MD

    Recruiting

  • D&H Pompano Research Center, LLC

    Margate, Florida, 33063

    Mazyar Rouhani, MD

    Recruiting

  • Southwest Rheumatology Research

    Mesquite, Texas, 75150

    Atul Singhal, MD

    Recruiting

  • Panax Clinical Research

    Miami, Florida, 33014

    Robert Perry, MD

    Recruiting

  • Anchor Medical Research

    Miami, Florida, 33176

    Juvenal Martinez, MD

    Recruiting

  • Velocity Clinical Research

    Norfolk, Nebraska, 68701

    Charles Harper, MD

    Recruiting

  • MD Medical Research

    Oxon Hill, Maryland, 20745

    Stephen Ong, MD

    Recruiting

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 85032

    Nita Kumar, MD

    Recruiting

  • AARA Clinical Research-Arthritis and Rheumatism Associates

    Rockville, Maryland, 20850

    Evan Siegel, MD

    Recruiting

  • Clinical Research Institute of Michigan

    Saint Clair Shores, Michigan, 48081

    Amar Majjhoo, MD

    Recruiting

  • Discovery Clinical Trials, LLC

    San Antonio, Texas, 78229

    Abha Gyani, MD

    Recruiting

  • Shelby Clinical Research

    Shelby, North Carolina, 28150

    Christian Martin, MD

    Recruiting

  • Premier Health Research

    Sparta, New Jersey, 07871

    Haroon Sarwar, MD

    Recruiting

  • Revival Research Institute

    Sterling Heights, Michigan, 48313

    Syed Husain, MD

    Recruiting

  • Cohen Medical Center

    Thousand Oaks, California, 91360

    Shariar Cohen-Gadol, MD

    Recruiting

  • DM Clinical Research

    Tomball, Texas, 77375

    Shaikh Ali, MD

    Recruiting

  • Oakland Medical Research Center

    Troy, Michigan, 48085

    Jay Sandberg, MD

    Recruiting

  • AARA Clinical Research-SE Tucson

    Tucson, Arizona, 85748

    Romy Cabacungan, MD

    Recruiting

  • Solace Clinical Research

    Tustin, California, 92780

    Roger Kornu, MD

    Recruiting

  • Velocity Clinical Research (Impact Research Institute)

    Waco, Texas, 76710

    Hing-Sheung Fung, MD

    Recruiting

  • Digestive Health Research of North Texas

    Wichita Falls, Texas, 76301

    Vanya Wagler, MD

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Conditions
Gout
Being tested
Dotinurad, Placebo
Keywords
Dotinurad, Xanthine Oxidase Inhibitors
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DotinuradDrug

    Over-encapsulated tablets containing active drug substance administered orally.

  • PlaceboOther

    Capsules containing microcrystalline cellulose administered orally.

Study groups in NCT07535034
Study groupRoleWhat they receive
DotinuradExperimentalThe Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take dotinurad (Treatment Period 1) followed by a 12-week period where participants will continue to take dotinurad (Treatment Period 2).
Receives: Drug: Dotinurad
Placebo + Placebo to DotinuardExperimentalThe Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take placebo (Treatment Period 1) followed by a 12-week treatment period where participants will take dotinurad (Treatment Period 2).
Receives: Drug: Dotinurad; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24

    Measured: Week 24

Secondary outcomes (7)

  1. Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24

    Measured: Weeks 16, 20 and 24

  2. Percentage of Participants With an sUA Level <6.0 <5.0, <4.0, and <3.0 mg/dL at Each Visit

    Measured: Up to Week 40

  3. Mean Change From Baseline in sUA at Week 24

    Measured: Baseline and Week 24

  4. Absolute Change from Baseline in sUA Levels at Each Visit

    Measured: Baseline to Week 40

  5. Percent Change from Baseline in sUA Levels at Each Visit

    Measured: Baseline to Week 40

  6. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Treatment Periods 1 and 2

    Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion.

    Measured: Screening to Week 36

  7. Number of Participants With TEAEs and SAEs Throughout the Study

    Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion.

    Measured: Screening to Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start8 May 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07535034
Sponsor's protocol ID
FYU-981-CRYS-201
Status last verified
Sep 2026
First submitted
10 Apr 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported for publication, after deidentification.

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