A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

September 1, 2026 updated by: Crystalys Therapeutics

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous Gout

The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with tophaceous gout.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

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 Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Withdrawn
        • Alabama Clinical Therapeutics
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The Kirklin Clinic of University of Alabama Birmingham Hospital
        • Contact:
          • Kenneth Saag, MD
      • Foley, Alabama, United States, 36535
        • Recruiting
        • G & L Research
        • Contact:
          • Nidal Morrar, MD
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
        • Contact:
          • Daniel Kreutz, MD
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
        • Contact:
          • Nehad Soloman, MD
      • Mesa, Arizona, United States, 85210
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
        • Contact:
          • Swati Bharadwaj, MD
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Del Sol Research Management - Tucson East
        • Contact:
          • Vicki Kalen, MD
    • California
      • Covina, California, United States, 91722
        • Recruiting
        • Medvin Clinical Research - Covina
        • Contact:
          • Samy Metyas, MD
      • Dublin, California, United States, 94568
        • Recruiting
        • West Coast Research
        • Contact:
        • Principal Investigator:
          • Alfred Tan, MD
      • Menifee, California, United States, 92586
        • Recruiting
        • Southland Arthritis and Osteoporosis Medical Center, Inc
        • Contact:
          • Amal Mehta, MD
      • Norco, California, United States, 92860
        • Recruiting
        • Infinity Clinical Research
        • Contact:
          • Peter Mattar, MD
      • Northridge, California, United States, 91324
        • Recruiting
        • Amicis Research Center - Balboa
        • Contact:
          • Pascal Dabel, MD
      • Orange, California, United States, 92866
        • Recruiting
        • Cure Clinical Research, LLC
        • Contact:
          • Ramprasad (Ram) Dandillaya, MD
      • Pomona, California, United States, 91767
        • Withdrawn
        • Dream Team Clinical Research
      • San Bernardino, California, United States, 92408
        • Recruiting
        • Velocity Clinical Research - San Bernardino
        • Contact:
          • Judith Albay, MD
      • San Diego, California, United States, 92120
        • Recruiting
        • Acclaim Clinical Research, Inc.
        • Contact:
          • Julie Vu, MD
      • San Leandro, California, United States, 94578
        • Recruiting
        • East Bay Rheumatology Medical Group
        • Contact:
          • Suneet Grewal, MD
      • Spring Valley, California, United States, 91978
        • Recruiting
        • BTC Network - Encompass Clinical Research
        • Contact:
          • Hanid Audish, MD
      • Thousand Oaks, California, United States, 91360-3967
        • Recruiting
        • Cohen Medical Centers
        • Contact:
          • Shariar Cohen-Gadol, MD
      • Tujunga, California, United States, 91042
        • Recruiting
        • Medvin Clinical Research - Tujunga
        • Contact:
          • Dan La, MD
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Denver Arthritis Clinic - Lowry
        • Contact:
          • Christopher Antolini, MD
    • Florida
      • Bradenton, Florida, United States, 34205
        • Recruiting
        • Bradenton Research Center
        • Contact:
          • Erick Folkens, MD
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Herco Medical and Research Center, Inc
        • Contact:
          • Eddy Capote, MD
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Best Quality Research
        • Contact:
          • Gustavo Ledo-Sanchez, MD
      • Hialeah, Florida, United States, 32016
        • 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 Center Florida
        • Contact:
          • Michael Gimness, MD
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Pompano Research Center
        • Contact:
          • Mazyar Rouhani, MD
      • Miami, Florida, United States, 33173
        • Recruiting
        • Well Pharma Medical Research
        • Contact:
          • Eddie Armas, MD
      • Miami, Florida, United States, 33176
        • Recruiting
        • Anchor Medical Research, LLC
        • Contact:
          • Juvental Martinez, MD
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Panax Clinical Research
        • Contact:
          • Robert G. Perry, MD
      • Orlando, Florida, United States, 32808
        • Recruiting
        • Omega Research DeBary
        • Contact:
          • Kwabena Ayesu, MD
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Clinical Research Trials of Florida
        • Contact:
        • Principal Investigator:
          • Sady Alpizar, MD
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research - Winter Park
        • Contact:
          • Anand Patel, 32789
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Withdrawn
        • DelRicht Research - Atlanta
      • Decatur, Georgia, United States, 30034
        • Recruiting
        • SKYCRNG - Rophe Adult and Pediatric Medicine
        • Contact:
          • Dwight Blake, MD
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Chicago Clinical Research Institute, Inc. (CCRII)
        • Principal Investigator:
          • Dennis Levinson, MD
        • Contact:
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
        • Contact:
          • Manish Jain, MD
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Gateway Clinical Trials
        • Contact:
          • Christopher Anderson, MD
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Recruiting
        • MediSphere Medical Research Center, LLC - East
        • Contact:
          • Hubert Reyes, MD
      • Indianapolis, Indiana, United States, 46202
        • Withdrawn
        • Delricht Research - Better Life Direct Primary Care
    • Kansas
      • Overland Park, Kansas, United States, 66223
        • Recruiting
        • Delricht Research - Concierge And Direct Primary Care
        • Contact:
          • Jonathan T. Jacobs, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • DelRicht Research - Louisville (Derby City DPC)
        • Contact:
          • Michael Lovelace, MD
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Active, not recruiting
        • Tandem Clinical Research - Metairie Clinic
      • New Orleans, Louisiana, United States, 70124
        • Recruiting
        • DelRicht Research - LCMC Health Urgent Care - Lakeview
        • Principal Investigator:
          • Patrick Dennis, MD
        • Contact:
      • Prairieville, Louisiana, United States, 70769
        • Recruiting
        • DelRicht Research - Prairieville
        • Principal Investigator:
          • Taylor Sanders, MD
        • Contact:
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Recruiting
        • MD Medical Research - Oxon Hill
        • Contact:
          • Stephen Ong, MD
      • Rockville, Maryland, United States, 20852
        • Withdrawn
        • DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research
        • Contact:
          • David DiBenedetto, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • A. Alfred Taubman Health Care Center
        • Contact:
          • Puja Khanna, 48109
      • Saint Clair Shores, Michigan, United States, 48081
        • Recruiting
        • Clinical Research Institute of Michigan - St. Clair Shores
        • Contact:
          • Amar Majjhoo, MD
      • Southfield, Michigan, United States, 48076
        • Withdrawn
        • DM Clinical Research - Detroit
      • Sterling Heights, Michigan, United States, 48313
        • Recruiting
        • Revival Research Institute - Sterling Heights
        • Contact:
          • Syed Husain, MD
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Oakland Medical Center
        • Contact:
          • Jay Sandberg, MD
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Withdrawn
        • Delricht Research - Command Family Medicine
      • Town and Country, Missouri, United States, 63017
        • Recruiting
        • DelRicht Research - Town and Country
        • Contact:
          • Amy E. Roberts, MD
    • Montana
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Boeson Research - Great Falls
        • Contact:
          • Richard Horng-Chy Lai, MD
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Recruiting
        • Las Vegas Clinical Trials
        • Contact:
          • Alton Walters, MD
    • New Jersey
      • Oradell, New Jersey, United States, 07649
        • Recruiting
        • Curalta Clinical Trials
        • Contact:
          • Vincent Giacalone, MD
      • Sparta, New Jersey, United States, 07871
        • Recruiting
        • Premier Health Research
        • Contact:
          • Haroon Sarwar, MD
      • West Long Branch, New Jersey, United States, 07764
        • Recruiting
        • Sahni Rheumatology & Therapy
        • Contact:
          • Kiren Sahni, MD
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • Ellipsis Research Group
        • Contact:
          • Jorge Serje, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • Michael Pillinger, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • DelRicht Research
        • Contact:
          • Olabisi Badmus, MD
      • Greensboro, North Carolina, United States, 27410
        • Recruiting
        • Triad Clinical Trials
        • Contact:
          • Richard Montgomery, MD
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Shelby Clinical Research, LLC - North Carolina
        • Contact:
          • Christian Martin, MD
    • Ohio
      • Dayton, Ohio, United States, 45424
        • Recruiting
        • Hometown Urgent Care and Research - Dayton
        • Contact:
          • Steve Choi, MD
      • Mason, Ohio, United States, 45040
        • Withdrawn
        • Delricht Research - Concierge Medicine Of Cincinnati
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Withdrawn
        • DelRicht Research - Tulsa
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Recruiting
        • Preferred Primary Care Physicians - Matthew Drive
        • Contact:
          • Christopher Labuda, MD
      • West Chester, Pennsylvania, United States, 19380
        • Withdrawn
        • Suburban Research Associates - West Chester Office
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Coastal Carolina Research Center - Main
        • Contact:
          • Rica Santiago, MD
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Recruiting
        • Health Concepts
        • Contact:
          • Richard Beasley, MD
    • Tennessee
      • Hendersonville, Tennessee, United States, 37075
        • Withdrawn
        • DelRicht Research - Hendersonville
    • Texas
      • Corpus Christi, Texas, United States, 78415
        • Recruiting
        • Arthritis & Osteoporosis Center of Coastal Bend
        • Contact:
          • Eric Chiang, MD
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Zenos Clinical Research
        • Contact:
          • Durga Tanneru, MD
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Epic Medical Research - DeSoto
        • Contact:
          • Haresh Boghara, MD
      • Denton, Texas, United States, 76205
        • Recruiting
        • Lone Star Arthritis & Rheumatology Associates - Denton
        • Contact:
          • Awilda (Michelle) Luciano, MD
      • Houston, Texas, United States, 77099
        • Recruiting
        • Pioneeer Research Solutions
        • Principal Investigator:
          • Francisco Velazquez, MD
        • Contact:
      • Houston, Texas, United States, 77027
        • Recruiting
        • Prolato Clinical Research Center
        • Contact:
          • Michelle Eisenberg, MD
      • Hurst, Texas, United States, 76054
        • Recruiting
        • Epic Medical Research - Hurst
        • Contact:
          • Robert Strzinek, MD
      • Katy, Texas, United States, 77450
        • Recruiting
        • R & H Clinical Research - South Fry Road
        • Contact:
          • Maryam Khawari, MD
      • Lancaster, Texas, United States, 75146
        • Recruiting
        • Premise Clinical Research Center
        • Contact:
          • Josier Nisnisan, MD
      • Lewisville, Texas, United States, 75057
        • Recruiting
        • Alliance Clinical Lewisville (Epic Clinical Research)
        • Contact:
          • Manjoo Sharma, MD
      • Mesquite, Texas, United States, 75150
        • Recruiting
        • SouthWest Rheumatology Research
        • Contact:
          • Atul Singhal, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Discovery Clinical Trials
        • Contact:
          • Abha Gyani, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • ERG - Endeavor Clinical Trials
        • Contact:
          • Nitendra Agarwal, MD
      • San Marcos, Texas, United States, 78666
        • Recruiting
        • Epic Medical Research - San Marcos
        • Contact:
          • Maria Salinas, MD
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Siena Research Network
        • Contact:
          • Mehjabin Parkar, MD
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research - Tomball - Multiple Specialties
        • Contact:
          • Shaikh Ali, MD
      • Wichita Falls, Texas, United States, 76301
        • Recruiting
        • Digestive Health Research of North Texas
        • Contact:
          • Vanya Wagler, MD
    • Utah
      • Ogden, Utah, United States, 84404
        • Recruiting
        • Rio Clinical Trials - Corporate Office
        • Contact:
          • Stephen Bruce, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • Charlottesville Medical Research
        • Contact:
          • James Clark, MD
      • Virginia Beach, Virginia, United States, 23454
        • Recruiting
        • Gershon Pain Specialists
        • Contact:
          • Steven Gershon, 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

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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
  3. Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter.
  4. sUA level ≥5.0 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
  5. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
  6. 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 study 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. Hypersensitivity or intolerance to dotinurad or to colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs).
  4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
  5. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.

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
Intervention / Treatment
Active Comparator: Allopurinol
Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 76.
Drug: Allopurinol
Over-encapsulated tablets containing active drug substance administered orally (PO).
Experimental: Dotinurad
Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4), dotinurad 2 mg QD for the next 8 weeks (Weeks 5-12), and dotinurad 4 mg QD thereafter up through Week 76.
Drug: Dotinurad
Over-encapsulated tablets containing active drug substance administered PO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76
Time Frame: Week 76
Week 76
Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76
Time Frame: Week 76
Week 76
Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24
Time Frame: Week 24
Week 24
Mean Rate of Gout Flares Requiring Treatment from Week 36 Through Week 76
Time Frame: Week 36 through Week 76
Week 36 through Week 76
Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24 and No Gout Flares Requiring Treatment from Week 36 Through Week 76
Time Frame: Week 24 and Week 36 through Week 76
Week 24 and Week 36 through Week 76
Mean Change from Baseline in sUA at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Mean Percent Change from Baseline in the Sum of the Areas for all Target Tophi at Each Visit
Time Frame: Baseline to Week 80
Baseline to Week 80
Percentage of Participants who Do Not have a Gout Flare Requiring Treatment from Week 36 through Week 76
Time Frame: Week 36 through Week 76
Week 36 through Week 76
Percentage of Participants with an sUA Level <5.0 mg/dL at Each Visit
Time Frame: Up to Week 80
Up to Week 80
Percentage of Participants with an sUA Level <4.0 mg/dL at Each Visit
Time Frame: Up to Week 80
Up to Week 80
Percentage of Participants with an sUA Level <3.0 mg/dL at Each Visit
Time Frame: Up to Week 80
Up to Week 80
Absolute Change from Baseline in sUA Levels at Each Visit
Time Frame: Baseline to Week 80
Baseline to Week 80
Percent Change from Baseline in sUA Levels at Each Visit
Time Frame: Baseline to Week 80
Baseline to Week 80
Percentage of Participants with a Gout Flare Requiring Treatment at Each Month Between Week 24 and the End of Study
Time Frame: Week 24 to Week 80
Week 24 to Week 80
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Week 80
Up to Week 80
Percentage of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to Week 80
Up to Week 80

Collaborators and Investigators

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

Sponsor

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)

August 4, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 22, 2025

First Submitted That Met QC Criteria

July 22, 2025

First Posted (Actual)

July 28, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYU-981-CRYS-302
  • 2024-520207-84-00 (Ctis)

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

product manufactured in and exported from the U.S.

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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