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GoutPhase 3NCT07089875

A Study of Dotinurad Versus Allopurinol in Participants With Gout

A Phase 3 study testing Allopurinol and Dotinurad in people with Gout, run by Crystalys Therapeutics at 115 sites in 3 countries.

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 study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gout
What is being tested?
Allopurinol and Dotinurad
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
115 sitesin 3 countries
Study dates
1 Aug 2025to 29 Nov 2027
Phase
Phase 3

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.
  • Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records).
  • Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment as documented in the participant's medical history) up to 600 mg/day for at least 3 months prior to Screening and remain on their dosing regimen until Day 1.
  • sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 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 -35 Visit) and Screening Visit 2 (Day -7 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 study 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.
  • Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs.
  • 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, Hepatitis B Surface Antigen, or Hepatitis C antibodies 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 study compliance or may confound interpretation of study results.

Trial locations and contacts

115 sites in 3 countries. 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

115 sites in 3 countries

United States95 sites, 82 recruiting

  • Michigan Medicine - University of Michigan

    Ann Arbor, Michigan, 48109-5000

    Puja Khanna, MD

    Recruiting

  • DelRicht Research - Atlanta

    Atlanta, Georgia, 30329

    Withdrawn

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Kenneth Saag, MD

    Recruiting

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

    Withdrawn

  • Bradenton Research Center

    Bradenton, Florida, 34205

    Eric Folkens, MD

    Recruiting

  • Ellipsis Research Group

    Brooklyn, New York, 11215

    Jorge Serje, MD

    Recruiting

  • Investigators Research Group

    Brownsburg, Indiana, 46112

    Kenneth Maynard, MD

    Recruiting

  • DelRicht Research

    Charlotte, North Carolina, 28210

    Olabisi Badmus, MD

    Recruiting

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

    James Clark, MD

    Recruiting

  • Chicago Clinical Research Institute, Inc. (CCRII)

    Chicago, Illinois, 60607

    Manognya Sama

    Dennis Levinson, MD

    Recruiting

  • Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

    Chicago, Illinois, 60640

    Manish Jain, MD

    Recruiting

  • Herco Medical and Research Center, Inc

    Coral Gables, Florida, 33134

    Eddy Capote, MD

    Recruiting

  • Arthritis Care of Texas

    Corpus Christi, Texas, 78415

    Eric Chiang, MD

    Recruiting

  • Medvin Clinical Research - Covina

    Covina, California, 91722

    Samy Metyas, MD

    Recruiting

  • Zenos Clinical Research

    Dallas, Texas, 75230

    Durga Tanneru, MD

    Recruiting

  • Hometown Urgent Care and Research - Dayton

    Dayton, Ohio, 45424

    Steve Choi, MD

    Recruiting

  • Pediatrics & Adult Medicine/SKYCRNG

    Decatur, Georgia, 30034

    Michele Sewell, MD

    Recruiting

  • SKYCRNG - Rophe Adult and Pediatric Medicine

    Decatur, Georgia, 30034

    Dwight Blake, MD

    Recruiting

  • Lone Star Arthritis & Rheumatology Associates - Denton

    Denton, Texas, 76205

    Awilda (Michelle) Luciano, MD

    Recruiting

  • Denver Arthritis Clinic - Lowry

    Denver, Colorado, 80230

    Christopher Antolini, MD

    Recruiting

  • Epic Medical Research - DeSoto

    DeSoto, Texas, 75115

    Haresh Boghara, MD

    Recruiting

  • West Coast Research

    Dublin, California, 94568

    Tim Davis

    Alfred Tan, MD

    Recruiting

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

    Alan Kivitz, MD

    Recruiting

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

    Hubert Reyes, MD

    Recruiting

  • Healthcare Research Network - Tinley Park

    Flossmoor, Illinois, 60402

    Ronald Stumbris, MD

    Recruiting

  • G&L Research

    Foley, Alabama, 36535

    Nidal Morrar, MD

    Recruiting

  • Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert

    Gilbert, Arizona, 85297

    Daniel Kreutz, MD

    Recruiting

  • Arizona Arthritis & Rheumatology Associates (AARA) - Glendale

    Glendale, Arizona, 85306

    Nehad Soloman, MD

    Recruiting

  • Boeson Research - Great Falls

    Great Falls, Montana, 59405

    Richard Horng-Chy Lai, MD

    Recruiting

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

    Withdrawn

  • DelRicht Research - Hendersonville

    Hendersonville, Tennessee, 37075

    Withdrawn

  • New Generation of Medical Research

    Hialeah, Florida, 32016

    Karelia Ruiz, MD

    Recruiting

  • Best Quality Research

    Hialeah, Florida, 33016

    Gustavo Ledo-Sanchez, MD

    Recruiting

  • Prolato Clinical Research Center

    Houston, Texas, 77027

    Michelle Eisenberg, MD

    Recruiting

  • Pioneer Research Solutions

    Houston, Texas, 77099

    Mozaffari Shahin

    Francisco Velazquez, MD

    Recruiting

  • Epic Medical Research - Hurst

    Hurst, Texas, 76054

    Robert Strzinek, MD

    Recruiting

  • Delricht Research - Better Life Direct Primary Care

    Indianapolis, Indiana, 46202

    Withdrawn

  • 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 Center Florida

    Lakeland, Florida, 33805

    Michael Gimness, MD

    Recruiting

  • Alliance Clinical Lewisville (Epic Clinical Research)

    Lewisville, Texas, 75057

    Manjoo Sharma, MD

    Recruiting

  • DelRicht Research - Louisville (Derby City DPC)

    Louisville, Kentucky, 40205

    Michael Lovelace, MD

    Recruiting

  • Delricht Research - Concierge Medicine Of Cincinnati

    Mason, Ohio, 45040

    Withdrawn

  • Southland Arthritis and Osteoporosis Medical Center, Inc

    Menifee, California, 92586

    Amal Mehta, MD

    Recruiting

  • Arizona Arthritis & Rheumatology Associates (AARA) - Mesa

    Mesa, Arizona, 85110

    Swati Bharadwaj, MD

    Recruiting

  • Southwest Rheumatology Research

    Mesquite, Texas, 75150

    Atul Singhal, MD

    Recruiting

  • Tandem Clinical Research - Metairie Clinic

    Metairie, Louisiana, 70006

    Active, not recruiting

  • Anchor Medical Research, LLC

    Miami, Florida, 33176

    Juvenal Martinez, MD

    Recruiting

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

    Robert G. Perry, MD

    Recruiting

  • Carteret Medical Group LLC

    Morehead City, North Carolina, 28557

    Mary Lawrence, MD

    Recruiting

  • DelRicht Research - LCMC Health Urgent Care - Lakeview

    New Orleans, Louisiana, 70124

    Emily Krambeck

    Patrick Dennis, MD

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Michael Pillinger, MD

    Recruiting

  • Infinity Clinical Research

    Norco, California, 92860

    Peter Mattar, MD

    Recruiting

  • Coastal Carolina Research Center - Main

    North Charleston, South Carolina, 29405

    Rica Santiago, MD

    Recruiting

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

    Alton Walters, MD

    Recruiting

  • Amicis Research Center - Balboa

    Northridge, California, 91324

    Pascal Dabel, MD

    Recruiting

  • Gateway Clinical Trials

    O'Fallon, Illinois, 62269

    Christopher Anderson, MD

    Recruiting

  • Ogden Clinic Canyon View/RIO Clinical Trials

    Ogden, Utah, 84404

    Stephen Bruce, MD

    Recruiting

  • Curalta Clinical Trials

    Oradell, New Jersey, 07649

    Vincent Giacalone, MD

    Recruiting

  • Omega Research DeBary

    Orlando, Florida, 32808

    Kwabena Ayesu, MD

    Recruiting

  • Delricht Research - Concierge And Direct Primary Care

    Overland Park, Kansas, 66223

    Jonathan T. Jacobs, MD

    Recruiting

  • MD Medical Research - Oxon Hill

    Oxon Hill, Maryland, 20745

    Stephen Ong, MD

    Recruiting

  • Dream Team Clinical Research

    Pomona, California, 91767

    Withdrawn

  • D&H Pompano Research Center

    Pompano Beach, Florida, 33064

    Mazyar Rouhani, MD

    Recruiting

  • DelRicht Research - Prairieville

    Prairieville, Louisiana, 70769

    Brittany Bolton

    Taylor Sanders, MD

    Recruiting

  • Health Concepts

    Rapid City, South Dakota, 57702

    Richard Beasley, MD

    Recruiting

  • DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)

    Rockville, Maryland, 20852

    Withdrawn

  • Clinical Research Institute of Michigan - St. Clair Shores

    Saint Clair Shores, Michigan, 48081

    Amar Majjhoo, MD

    Recruiting

  • Discovery Clinical Trials

    San Antonio, Texas, 78229

    Abha Gyani, MD

    Recruiting

  • ERG - Endeavor Clinical Trials

    San Antonio, Texas, 78240

    Nitendra Agarwal, MD

    Recruiting

  • Velocity Clinical Research - San Bernardino

    San Bernardino, California, 92408

    Judith Albay, MD

    Recruiting

  • Acclaim Clinical Research, Inc.

    San Diego, California, 92120

    Julie Vu, MD

    Recruiting

  • East Bay Rheumatology Medical Group

    San Leandro, California, 94578

    Suneet Grewal, MD

    Recruiting

  • Epic Medical Research - San Marcos

    San Marcos, Texas, 78666

    Maria De Jesus Salinas, MD

    Recruiting

  • Shelby Clinical Research, LLC - North Carolina

    Shelby, North Carolina, 28150

    Christian Martin, MD

    Recruiting

  • DM Clinical Research - Detroit

    Southfield, Michigan, 48076

    Withdrawn

  • Premier Health Research

    Sparta, New Jersey, 07871

    Haroon Sarwar, MD

    Recruiting

  • BTC Network - Encompass Clinical Research

    Spring Valley, California, 91978

    Hanid Audish, MD

    Recruiting

  • Delricht Research - Command Family Medicine

    Springfield, Missouri, 65807

    Withdrawn

  • Revive Research Institute - Sterling Heights

    Sterling Heights, Michigan, 48313

    Syed Ali Muttaqi Husain, MD

    Recruiting

  • Siena Research Network

    Sugar Land, Texas, 77479

    Mehjabin Parkar, MD

    Recruiting

  • Clinical Research Trials of Florida

    Tampa, Florida, 33607

    Viviana Fonseca

    Sady Alpizar, MD

    Recruiting

  • Cohen Medical Centers

    Thousand Oaks, California, 91360-3967

    Shariar Cohen-Gadol, MD

    Recruiting

  • DM Clinical Research - Tomball - Multiple Specialties

    Tomball, Texas, 77375

    Shaikh Ali, MD

    Recruiting

  • DelRicht Research - Town and Country

    Town and Country, Missouri, 63017

    Amy E. Roberts, MD

    Recruiting

  • Oakland Medical Center

    Troy, Michigan, 48085

    Jay Sandberg, MD

    Recruiting

  • Del Sol Research Management - Tucson East

    Tucson, Arizona, 85715

    Vicki Kalen, MD

    Recruiting

  • Medvin Clinical Research - Tujunga

    Tujunga, California, 91042

    Dan La, MD

    Recruiting

  • DelRicht Research - Tulsa

    Tulsa, Oklahoma, 74133

    Withdrawn

  • Gershon Pain Specialists

    Virginia Beach, Virginia, 23454

    Steven Gershon, MD

    Recruiting

  • MedVadis Research

    Waltham, Massachusetts, 02451

    David DiBenedetto, MD

    Recruiting

  • Suburban Research Associates - West Chester Office

    West Chester, Pennsylvania, 19380

    Withdrawn

  • Sahni Rheumatology & Therapy

    West Long Branch, New Jersey, 07764

    Kiren Sahni, MD

    Recruiting

  • Digestive Health Research of North Texas

    Wichita Falls, Texas, 76301

    Vanya Wagler, MD

    Recruiting

  • Conquest Research - Winter Park

    Winter Park, Florida, 32789

    Anand Patel, MD

    Recruiting

Other trials in United States

Poland13 sites, 13 recruiting

  • Inter Clinic

    Bialystok, Podlaskie Voivodeship, 15-077

    Piotr Klimiuk, MD

    Recruiting

  • ClinicMed Daniluk Nowak Spółka Komandytowa

    Bialystok, Podlaskie Voivodeship, 15-879

    Stefan Daniluk, MD

    Recruiting

  • FutureMeds Gdynia

    Gdynia, Pomeranian Voivodeship, 81-537

    Barbara Grabowicz-Waśko, MD

    Recruiting

  • Pro Familia - Katowice

    Katowice, Silesian Voivodeship, 40-122

    Danuta Wronska, MD

    Recruiting

  • Silmedic sp. z o.o.

    Katowice, Silesian Voivodeship, 40-282

    Karina Sitek-Ziolkowska, MD

    Recruiting

  • FutureMeds - Krakow

    Krakow, Lesser Poland Voivodeship, 31-501

    Weronika Kleczynska-Szpakiewicz, MD

    Recruiting

  • Innova Clinic

    Plońsk, Masovian Voivodeship, 09-100

    Tomasz Wysocki, MD

    Recruiting

  • Centrum Medyczne Solumed

    Poznan, Greater Poland Voivodeship, 60-529

    Kamilla Klama, MD

    Recruiting

  • Prolato Clinical Research Center

    Sochaczew, Masovian Voivodeship, 96-500

    Monika Wronisz, MD

    Recruiting

  • Medicover Integrated Clinical Services- MICS Centrum Medyczne Warszawa Chlodna

    Warsaw, Masovian Voivodeship, 00-872

    Magdalena Szuflińska-Sidorowicz, MD

    Recruiting

  • FutureMeds - Targówek

    Warsaw, Masovian Voivodeship, 03-291

    Agnieszka Jurek-Urbanowska, MD

    Recruiting

  • Med-Progress Ośrodek Nowoczesnego Leczenia

    Wejherowo, Pomeranian Voivodeship, 84-200

    Maciej Osińsk, MD

    Recruiting

  • FutureMeds - Wroclaw

    Wroclaw, Lower Silesian Voivodeship, 53-673

    Ewa Krecipro-Nizińska, MD

    Recruiting

Other trials in Poland

Spain7 sites, 7 recruiting

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

    Francisco Javier Blanco Garcia, MD

    Recruiting

  • Accellacare - Alcobendas

    Alcobendas, Madrid, 28100

    Gualberto Diaz Saez, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Cesar Diaz-Torne, MD

    Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, 28032

    Enrique Calvo Aranda, MD

    Recruiting

  • Clínica Gaias Santiago

    Santiago de Compostela, La Coruña, 15706

    Juan José Amarelo Ramos, MD

    Recruiting

  • Hospital Quirónsalud Infanta Luisa

    Seville, Sevilla, 41010

    Lola Fernández de la Fuente Bursón, MD

    Recruiting

  • Clínica NTDE - Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, Sevilla, 46010

    Alberto Aliaga Verdugo, MD

    Recruiting

Other trials in Spain

About this study

Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With 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 hyperuricemia associated with gout.

Conditions
Gout
Being tested
Allopurinol, Dotinurad
Keywords
Dotinurad, Allopurinol, Hyperuricemia
Medical subject headings
Gout, Hyperuricemia

What participants receive

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

  • AllopurinolDrug

    Over-encapsulated tablets containing active drug substance administered orally (PO).

  • DotinuradDrug

    Over-encapsulated tablets containing active drug substance administered PO.

Study groups in NCT07089875
Study groupRoleWhat they receive
AllopurinolActive comparatorParticipants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 64.
Receives: Drug: Allopurinol
Dotinurad 2 mg MaintenanceExperimentalParticipants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4) and then dotinurad 2 mg QD through Week 64.
Receives: Drug: Dotinurad
Dotinurad 4 mg MaintenanceExperimentalParticipants 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 through Week 64.
Receives: Drug: Dotinurad

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 (13)

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

    Measured: Weeks 16, 20 and 24

  2. Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64

    Measured: Week 36 through Week 64

  3. 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 64

    Measured: Week 24 and Week 36 through Week 64

  4. Mean Change From Baseline in sUA at Week 24

    Measured: Baseline and Week 24

  5. Percentage of Participants who do not Have a Gout Flare Requiring Treatment From Week 24 Through Week 64

    Measured: Week 24 through Week 64

  6. Percentage of Participants With an sUA Level <6.0 mg/dL at Each Visit

    Measured: Up to Week 68

  7. Percentage of Participants With an sUA Level <5.0 mg/dL at Each Visit

    Measured: Up to Week 68

  8. Percentage of Participants With an sUA Level <4.0 mg/dL at Each Visit

    Measured: Up to Week 68

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

    Measured: Baseline to Week 68

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

    Measured: Baseline to Week 68

  11. Percentage of Participants With a Gout Flare Requiring Treatment at Each Visit Between Week 24 and the end of Study

    Measured: Week 24 to Week 68

  12. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: Day 1 through Week 68

  13. Percentage of Participants With Serious Adverse Events (SAEs)

    Measured: Day 1 through Week 68

Timeline

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

  1. First posted28 Jul 2025
  2. Study start1 Aug 2025
  3. Primary completion29 Nov 2027 (estimated)
  4. Study completion29 Nov 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07089875
Sponsor's protocol ID
FYU-981-CRYS-301
Other IDs
2024-520206-19-00
Status last verified
Sep 2026
First submitted
22 Jul 2025
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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