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 119 sites in 3 countries.
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
- 119 sitesin 3 countries
- Study dates
- 1 Aug 2025to 29 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
119 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
119 sites in 3 countries
United States99 sites, 83 recruiting
- Recruiting
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109-5000
Puja Khanna, MD
- Withdrawn
DelRicht Research - Atlanta
Atlanta, Georgia, 30329
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Kenneth Saag, MD
- Withdrawn
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
- Recruiting
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
Triad Clinical Trials
Greensboro, North Carolina, 27410
Richard Montgomery, MD
- Withdrawn
Healthcare Research Network
Hazelwood, Missouri, 63042
- Withdrawn
DelRicht Research - Hendersonville
Hendersonville, Tennessee, 37075
- Recruiting
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
- Withdrawn
Delricht Research - Better Life Direct Primary Care
Indianapolis, Indiana, 46202
- 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 Center Florida
Lakeland, Florida, 33805
Michael Gimness, MD
- Withdrawn
Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville, Texas, 75057
- Recruiting
DelRicht Research - Louisville (Derby City DPC)
Louisville, Kentucky, 40205
Michael Lovelace, MD
- Withdrawn
Delricht Research - Concierge Medicine Of Cincinnati
Mason, Ohio, 45040
- Recruiting
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
- Withdrawn
Tandem Clinical Research - Metairie Clinic
Metairie, Louisiana, 70006
- Recruiting
Well Pharma Medical Research
Miami, Florida, 33173
Eddie Armas, MD
- 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
Cure Clinical Research
Orange, California, 92866
Ramprasad Dandillaya, 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
- Withdrawn
Dream Team Clinical Research
Pomona, California, 91767
- Recruiting
D&H Pompano Research Center
Pompano Beach, Florida, 33064
Mazyar Rouhani, MD
- Withdrawn
DelRicht Research - Prairieville
Prairieville, Louisiana, 70769
- Recruiting
Health Concepts
Rapid City, South Dakota, 57702
Richard Beasley, MD
- Withdrawn
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
Rockville, Maryland, 20852
- Recruiting
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
- Withdrawn
DM Clinical Research - Detroit
Southfield, Michigan, 48076
- Recruiting
Premier Health Research
Sparta, New Jersey, 07871
Haroon Sarwar, MD
- Recruiting
BTC Network - Encompass Clinical Research
Spring Valley, California, 91978
Hanid Audish, MD
- Withdrawn
Delricht Research - Command Family Medicine
Springfield, Missouri, 65807
- Recruiting
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
- Withdrawn
Medvin Clinical Research - Tujunga
Tujunga, California, 91042
- Withdrawn
DelRicht Research - Tulsa
Tulsa, Oklahoma, 74133
- Recruiting
Gershon Pain Specialists
Virginia Beach, Virginia, 23454
Steven Gershon, MD
- Recruiting
MedVadis Research
Waltham, Massachusetts, 02451
David DiBenedetto, MD
- Withdrawn
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, 19380
- Recruiting
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
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
Elana Eisner, MD
- Recruiting
Conquest Research - Winter Park
Winter Park, Florida, 32789
Anand Patel, MD
Poland13 sites, 13 recruiting
- 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
Spain7 sites, 7 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Allopurinol | Active comparator | Participants 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 Maintenance | Experimental | Participants 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 Maintenance | Experimental | 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 through Week 64. Receives: Drug: Dotinurad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Measured: Week 24
Secondary outcomes (13)
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive
Measured: Weeks 16, 20 and 24
Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64
Measured: Week 36 through Week 64
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
Mean Change From Baseline in sUA at Week 24
Measured: Baseline and Week 24
Percentage of Participants who do not Have a Gout Flare Requiring Treatment From Week 24 Through Week 64
Measured: Week 24 through Week 64
Percentage of Participants With an sUA Level <6.0 mg/dL at Each Visit
Measured: Up to Week 68
Percentage of Participants With an sUA Level <5.0 mg/dL at Each Visit
Measured: Up to Week 68
Percentage of Participants With an sUA Level <4.0 mg/dL at Each Visit
Measured: Up to Week 68
Absolute Change from Baseline in sUA Levels at Each Visit
Measured: Baseline to Week 68
Percent Change from Baseline in sUA Levels at Each Visit
Measured: Baseline to Week 68
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
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 through Week 68
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.
- First posted28 Jul 2025
- Study start1 Aug 2025
- Primary completion29 Nov 2027 (estimated)
- Study completion29 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Crystalys Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
- Oct 2026
- First submitted
- 22 Jul 2025
- Last updated
- 29 Oct 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07089875
- Acronym / sponsor ID
- FYU-981-CRYS-301
- Conditions
- Gout
- Keywords
- Dotinurad, Allopurinol, Hyperuricemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Crystalys TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Active comparator | Drug: AllopurinolParticipants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 64. |
| Dotinurad 2 mg Maintenance | Experimental | Drug: DotinuradParticipants 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. |
| Dotinurad 4 mg Maintenance | Experimental | Drug: DotinuradParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolOver-encapsulated tablets containing active drug substance administered orally (PO). | Drug | Allopurinol |
| DotinuradOver-encapsulated tablets containing active drug substance administered PO. | Drug | Dotinurad 2 mg Maintenance, Dotinurad 4 mg Maintenance |
Primary outcome
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Time frame: Week 24
13 secondary outcomes
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive
Time frame: Weeks 16, 20 and 24
Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64
Time frame: Week 36 through Week 64
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
Time frame: Week 24 and Week 36 through Week 64
Mean Change From Baseline in sUA at Week 24
Time frame: Baseline and Week 24
Percentage of Participants who do not Have a Gout Flare Requiring Treatment From Week 24 Through Week 64
Time frame: Week 24 through Week 64
Percentage of Participants With an sUA Level <6.0 mg/dL at Each Visit
Time frame: Up to Week 68
Percentage of Participants With an sUA Level <5.0 mg/dL at Each Visit
Time frame: Up to Week 68
Percentage of Participants With an sUA Level <4.0 mg/dL at Each Visit
Time frame: Up to Week 68
Absolute Change from Baseline in sUA Levels at Each Visit
Time frame: Baseline to Week 68
Percent Change from Baseline in sUA Levels at Each Visit
Time frame: Baseline to Week 68
Percentage of Participants With a Gout Flare Requiring Treatment at Each Visit Between Week 24 and the end of Study
Time frame: Week 24 to Week 68
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Week 68
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Day 1 through Week 68
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported for publication, after deidentification.
Related trials for Gout
RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Recruiting
Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
Gout, Gouty Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
119 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allopurinol and Dotinurad in people with Gout, run by Crystalys Therapeutics at 119 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in United States, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Lead (1-858-379-2316, ClinicalTrials@crystalystx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.