A Study of Dotinurad Versus Allopurinol in Participants With Gout
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
2 other identifiers
interventional
500
3 countries
95
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2025
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 29, 2027
April 28, 2026
April 1, 2026
2.3 years
July 22, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Week 24
Secondary Outcomes (13)
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive
Weeks 16, 20 and 24
Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64
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
Week 24 and Week 36 through Week 64
Mean Change From Baseline in sUA at Week 24
Baseline and Week 24
Percentage of Participants who do not Have a Gout Flare Requiring Treatment From Week 24 Through Week 64
Week 24 through Week 64
- +8 more secondary outcomes
Study Arms (3)
Allopurinol
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Over-encapsulated tablets containing active drug substance administered orally (PO).
Over-encapsulated tablets containing active drug substance administered PO.
Eligibility Criteria
You may qualify if:
- 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) 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.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, Arizona, 85297, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, Arizona, 85306, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, Arizona, 85110, United States
Del Sol Research Management - Tucson East
Tucson, Arizona, 85715, United States
Del Sol Research Management - Tucson
Tucson, Arizona, 85715, United States
Medvin Clinical Research - Covina
Covina, California, 91722, United States
West Coast Research
Dublin, California, 94568, United States
Infinity Clinical Research
Norco, California, 92860, United States
Amicis Research Center - Balboa
Northridge, California, 91324, United States
Dream Team Clinical Research
Pomona, California, 91767, United States
Velocity Clinical Research - San Bernardino
San Bernardino, California, 92408, United States
Acclaim Clinical Research, Inc.
San Diego, California, 92120, United States
East Bay Rheumatology Medical Group
San Leandro, California, 94578, United States
BTC Network - Encompass Clinical Research
Spring Valley, California, 91978, United States
Cohen Medical Centers
Thousand Oaks, California, 91360-3967, United States
Medvin Clinical Research - Tujunga
Tujunga, California, 91042, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, 80230, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
Herco Medical and Research Center, Inc
Coral Gables, Florida, 33134, United States
New Generation of Medical Research
Hialeah, Florida, 32016, United States
Best Quality Research
Hialeah, Florida, 33016, United States
Health Awareness Inc
Jupiter, Florida, 33458, United States
Clinical Research of Center Florida
Lakeland, Florida, 33805, United States
Anchor Medical Research, LLC
Miami, Florida, 33176, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Omega Research DeBary
Orlando, Florida, 32808, United States
D&H Pompano Research Center
Pompano Beach, Florida, 33064, United States
Clinical Research Trials of Florida
Tampa, Florida, 33607, United States
DelRicht Research - Atlanta
Atlanta, Georgia, 30329, United States
Chicago Clinical Research Institute, Inc. (CCRII)
Chicago, Illinois, 60607, United States
Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
Chicago, Illinois, 60640, United States
Healthcare Research Network - Tinley Park
Flossmoor, Illinois, 60402, United States
Investigators Research Group
Brownsburg, Indiana, 46112, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Delricht Research - Better Life Direct Primary Care
Indianapolis, Indiana, 46202, United States
Delricht Research - Concierge And Direct Primary Care
Overland Park, Kansas, 66223, United States
DelRicht Research - Louisville (Derby City DPC)
Louisville, Kentucky, 40205, United States
Tandem Clinical Research - Metairie Clinic
Metairie, Louisiana, 70006, United States
DelRicht Research - LCMC Health Urgent Care - Lakeview
New Orleans, Louisiana, 70124, United States
DelRicht Research - Prairieville
Prairieville, Louisiana, 70769, United States
MD Medical Research - Oxon Hill
Oxon Hill, Maryland, 20745, United States
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
Rockville, Maryland, 20852, United States
MedVadis Research
Waltham, Massachusetts, 02451, United States
Clinical Research Institute of Michigan - St. Clair Shores
Saint Clair Shores, Michigan, 48081, United States
DM Clinical Research - Detroit
Southfield, Michigan, 48076, United States
Oakland Medical Center
Troy, Michigan, 48085, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
Delricht Research - Command Family Medicine
Springfield, Missouri, 65807, United States
DelRicht Research - Town and Country
Town and Country, Missouri, 63017, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
Ellipsis Research Group
Brooklyn, New York, 11215, United States
NYU Langone Health
New York, New York, 10016, United States
DelRicht Research - Charlotte (Direct Primary Care - DPC)
Charlotte, North Carolina, 28205, United States
Carteret Medical Group LLC
Morehead City, North Carolina, 28557, United States
Shelby Clinical Research, LLC - North Carolina
Shelby, North Carolina, 28150, United States
Hometown Urgent Care and Research - Dayton
Dayton, Ohio, 45424, United States
Delricht Research - Concierge Medicine Of Cincinnati
Mason, Ohio, 45040, United States
DelRicht Research - Tulsa
Tulsa, Oklahoma, 74133, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, 19380, United States
Coastal Carolina Research Center - Main
North Charleston, South Carolina, 29405, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
DelRicht Research - Hendersonville
Hendersonville, Tennessee, 37075, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
Lone Star Arthritis & Rheumatology Associates - Denton
Denton, Texas, 76205, United States
Epic Medical Research - DeSoto
DeSoto, Texas, 75115, United States
Prolato Clinical Research Center
Houston, Texas, 77027, United States
Pioneer Research Solutions
Houston, Texas, 77099, United States
Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville, Texas, 75057, United States
Southwest Rheumatology Research
Mesquite, Texas, 75150, United States
Discovery Clinical Trials
San Antonio, Texas, 78229, United States
ERG - Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas, 77375, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Centrum Medyczne Solumed
Poznan, Greater Poland Voivodeship, 60-529, Poland
FutureMeds - Krakow
Krakow, Lesser Poland Voivodeship, 31-501, Poland
FutureMeds - Wroclaw
Wroclaw, Lower Silesian Voivodeship, 53-673, Poland
Innova Clinic
Plońsk, Masovian Voivodeship, 09-100, Poland
Prolato Clinical Research Center
Sochaczew, Masovian Voivodeship, 96-500, Poland
Medicover Integrated Clinical Services- MICS Centrum Medyczne Warszawa Chlodna
Warsaw, Masovian Voivodeship, 00-872, Poland
FutureMeds - Targówek
Warsaw, Masovian Voivodeship, 03-291, Poland
ClinicMed Daniluk, Nowak Spółka Komandytowa
Bialystok, Podlaskie Voivodeship, 15-879, Poland
FutureMeds Gdynia
Gdynia, Pomeranian Voivodeship, 81-537, Poland
Med-Progress Ośrodek Nowoczesnego Leczenia
Wejherowo, Pomeranian Voivodeship, 84-200, Poland
Pro Familia - Katowice
Katowice, Silesian Voivodeship, 40-122, Poland
Silmedic sp. z o.o.
Katowice, Silesian Voivodeship, 40-282, Poland
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006, Spain
Clínica Gaias Santiago
Santiago de Compostela, La Coruña, 15706, Spain
Accellacare - Alcobendas
Alcobendas, Madrid, 28100, Spain
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28032, Spain
Hospital Quirónsalud Infanta Luisa
Seville, Sevilla, 41010, Spain
Clínica NTDE - Nuevas Tecnologías en Diabetes y Endocrinología
Seville, Sevilla, 46010, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2025
First Posted
July 28, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
November 29, 2027
Study Completion (Estimated)
November 29, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
Individual participant data that underlie the results reported for publication, after deidentification.