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

September 1, 2026 updated by: Crystalys Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The Kirklin Clinic of UAB Hospital
        • Contact:
          • Kenneth Saag, MD
    • California
      • Granada Hills, California, United States, 91344
        • Recruiting
        • Amicis Research Center
        • Contact:
          • Pascal Dabel, MD
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Cohen Medical Center
        • Contact:
          • Shariar Cohen-Gadol, MD
      • Tustin, California, United States, 92780
        • Recruiting
        • Solace Clinical Research
        • Contact:
          • Roger Kornu, MD
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Denver Arthritis Clinic - Lowry
        • Contact:
          • Christopher Antolini, MD
    • Florida
      • DeBary, Florida, United States, 32713
        • Recruiting
        • OMEGA Research Group
        • Contact:
          • Kwabena Ayesu, MD
      • Flagami, Florida, United States, 33126
        • Recruiting
        • Herco Medical and Research Center, Inc
        • Contact:
          • Eddy Capote, MD
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • New Generation Of Medical Research
        • Contact:
          • Karelia Ruiz, MD
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Health Awareness, Inc.
        • Contact:
          • Ronald Surowitz, MD
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Clinical Research of Central Florida
        • Contact:
          • Michael Gimness, MD
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Pompano Research Center, LLC
        • Contact:
          • Mazyar Rouhani, MD
      • Miami, Florida, United States, 33014
        • Recruiting
        • Panax Clinical Research
        • Contact:
          • Robert Perry, MD
      • Miami, Florida, United States, 33176
        • Recruiting
        • Anchor Medical Research
        • Contact:
          • Juvenal Martinez, MD
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Southwest Atlanta Internal Medicine
        • Contact:
          • Tamara Brown, MD
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials
        • Contact:
          • Manish Jain, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Research Group of Lexington, LLC
        • Contact:
          • Justin Arambasick, MD
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Recruiting
        • MD Medical Research
        • Contact:
          • Stephen Ong, MD
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Recruiting
        • Clinical Research Institute of Michigan
        • Contact:
          • Amar Majjhoo, MD
      • Sterling Heights, Michigan, United States, 48313
        • Recruiting
        • Revival Research Institute
        • Contact:
          • Syed Husain, MD
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Oakland Medical Research Center
        • Contact:
          • Jay Sandberg, MD
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Recruiting
        • Velocity Clinical Research
        • Contact:
          • Charles Harper, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89030
        • Recruiting
        • Las Vegas Clinical Trials
        • Contact:
          • Alton Walters, MD
    • New Jersey
      • Sparta, New Jersey, United States, 07871
        • Recruiting
        • Premier Health Research
        • Contact:
          • Haroon Sarwar, MD
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • Ellipsis Research Group
        • Contact:
          • Jorge Serje, MD
      • Hartsdale, New York, United States, 10530
        • Recruiting
        • Drug Trials America
        • Contact:
          • Michael Gerdis, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • DJL Clinical Research
        • Contact:
          • Emily Jane Herron Box, MD
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Shelby Clinical Research
        • Contact:
          • Christian Martin, MD
    • Ohio
      • Dayton, Ohio, United States, 45424
        • Recruiting
        • Hometown Urgent Care and Research
        • Contact:
          • Carol Bland, MD
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Premier Research
        • Contact:
          • Susan Neese, MD
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Zenos Clinical Research
        • Contact:
          • Bachar Elsaadi, MD
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Epic Medical Research
        • Contact:
          • Haresh Boghara, MD
      • Houston, Texas, United States, 77479
        • Recruiting
        • Pioneer Research Solutions
        • Contact:
          • Francisco Velazquez, MD
      • Katy, Texas, United States, 77449
        • Recruiting
        • R&H Clinical Research - Westborough Drive
        • Contact:
          • Maryam Khawari, MD
      • Mesquite, Texas, United States, 75150
        • Recruiting
        • SouthWest Rheumatology Research
        • Contact:
          • Atul Singhal, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Discovery Clinical Trials, LLC
        • Contact:
          • Abha Gyani, MD
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research
        • Contact:
          • Shaikh Ali, MD
      • Waco, Texas, United States, 76710
        • Recruiting
        • Velocity Clinical Research (Impact Research Institute)
        • Contact:
          • Hing-Sheung Fung, MD
      • Wichita Falls, Texas, United States, 76301
        • Recruiting
        • Digestive Health Research of North Texas
        • Contact:
          • Vanya Wagler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dotinurad
The 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).
Drug: Dotinurad
Over-encapsulated tablets containing active drug substance administered orally.
Experimental: Placebo + Placebo to Dotinuard
The 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).
Drug: Dotinurad
Over-encapsulated tablets containing active drug substance administered orally.
Other: Placebo
Capsules containing microcrystalline cellulose administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in sUA at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24
Time Frame: Weeks 16, 20 and 24
Weeks 16, 20 and 24
Percentage of Participants With an sUA Level <6.0 <5.0, <4.0, and <3.0 mg/dL at Each Visit
Time Frame: Up to Week 40
Up to Week 40
Absolute Change from Baseline in sUA Levels at Each Visit
Time Frame: Baseline to Week 40
Baseline to Week 40
Percent Change from Baseline in sUA Levels at Each Visit
Time Frame: Baseline to Week 40
Baseline to Week 40
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Treatment Periods 1 and 2
Time Frame: Screening to Week 36
Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion.
Screening to Week 36
Number of Participants With TEAEs and SAEs Throughout the Study
Time Frame: Screening to Week 40
Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion.
Screening to Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Crystalys Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FYU-981-CRYS-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported for publication, after deidentification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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