A Study of Dotinurad Versus Allopurinol in Participants With Gout
NCT ID: NCT07089875
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2025-08-01
2027-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Allopurinol
Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 64.
Allopurinol
Over-encapsulated tablets containing active drug substance administered orally (PO).
Dotinurad 2 mg Maintenance
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.
Dotinurad
Over-encapsulated tablets containing active drug substance administered PO.
Dotinurad 4 mg Maintenance
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.
Dotinurad
Over-encapsulated tablets containing active drug substance administered PO.
Interventions
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Allopurinol
Over-encapsulated tablets containing active drug substance administered orally (PO).
Dotinurad
Over-encapsulated tablets containing active drug substance administered PO.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year.
3. 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).
4. 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.
5. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
6. 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.
7. 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
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.
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, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.
6. 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.
18 Years
75 Years
ALL
No
Sponsors
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Crystalys Therapeutics
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, Arizona, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, Arizona, United States
Del Sol Research Management - Tucson East
Tucson, Arizona, United States
Del Sol Research Management - Tucson
Tucson, Arizona, United States
Medvin Clinical Research - Covina
Covina, California, United States
West Coast Research
Dublin, California, United States
Infinity Clinical Research
Norco, California, United States
Amicis Research Center - Balboa
Northridge, California, United States
Dream Team Clinical Research
Pomona, California, United States
Velocity Clinical Research - San Bernardino
San Bernardino, California, United States
Acclaim Clinical Research, Inc.
San Diego, California, United States
East Bay Rheumatology Medical Group
San Leandro, California, United States
BTC Network - Encompass Clinical Research
Spring Valley, California, United States
Cohen Medical Centers
Thousand Oaks, California, United States
Medvin Clinical Research - Tujunga
Tujunga, California, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
Bradenton Research Center
Bradenton, Florida, United States
Herco Medical and Research Center, Inc
Coral Gables, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
Best Quality Research
Hialeah, Florida, United States
Health Awareness Inc
Jupiter, Florida, United States
Clinical Research of Center Florida
Lakeland, Florida, United States
Anchor Medical Research, LLC
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Omega Research DeBary
Orlando, Florida, United States
D&H Pompano Research Center
Pompano Beach, Florida, United States
Clinical Research Trials of Florida
Tampa, Florida, United States
DelRicht Research - Atlanta
Atlanta, Georgia, United States
Chicago Clinical Research Institute, Inc. (CCRII)
Chicago, Illinois, United States
Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
Chicago, Illinois, United States
Healthcare Research Network - Tinley Park
Flossmoor, Illinois, United States
Investigators Research Group
Brownsburg, Indiana, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Delricht Research - Better Life Direct Primary Care
Indianapolis, Indiana, United States
Delricht Research - Concierge And Direct Primary Care
Overland Park, Kansas, United States
DelRicht Research - Louisville (Derby City DPC)
Louisville, Kentucky, United States
Tandem Clinical Research - Metairie Clinic
Metairie, Louisiana, United States
DelRicht Research - LCMC Health Urgent Care - Lakeview
New Orleans, Louisiana, United States
DelRicht Research - Prairieville
Prairieville, Louisiana, United States
MD Medical Research - Oxon Hill
Oxon Hill, Maryland, United States
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
Rockville, Maryland, United States
MedVadis Research
Waltham, Massachusetts, United States
Clinical Research Institute of Michigan - St. Clair Shores
Saint Clair Shores, Michigan, United States
DM Clinical Research - Detroit
Southfield, Michigan, United States
Oakland Medical Center
Troy, Michigan, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Delricht Research - Command Family Medicine
Springfield, Missouri, United States
DelRicht Research - Town and Country
Town and Country, Missouri, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Ellipsis Research Group
Brooklyn, New York, United States
DelRicht Research - Charlotte (Direct Primary Care - DPC)
Charlotte, North Carolina, United States
Carteret Medical Group LLC
Morehead City, North Carolina, United States
Shelby Clinical Research, LLC - North Carolina
Shelby, North Carolina, United States
Hometown Urgent Care and Research - Dayton
Dayton, Ohio, United States
Delricht Research - Concierge Medicine Of Cincinnati
Mason, Ohio, United States
DelRicht Research - Tulsa
Tulsa, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, United States
Coastal Carolina Research Center - Main
North Charleston, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
DelRicht Research - Hendersonville
Hendersonville, Tennessee, United States
Zenos Clinical Research
Dallas, Texas, United States
Lone Star Arthritis & Rheumatology Associates - Denton
Denton, Texas, United States
Epic Medical Research - DeSoto
DeSoto, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville, Texas, United States
Discovery Clinical Trials
San Antonio, Texas, United States
DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Kenneth Saag, MD
Role: primary
Gregory Flippo, MD
Role: primary
Daniel Kreutz, MD
Role: primary
Nehad Soloman, MD
Role: primary
Swati Bharadwaj, MD
Role: primary
Vicki Kalen, MD
Role: primary
Vicki Kalen, MD
Role: primary
Samy Metyas, MD
Role: primary
Peter Mattar, MD
Role: primary
Pascal Dabel, MD
Role: primary
Quang Vo, MD
Role: primary
Judith Kirstein, MD
Role: primary
Suneet Grewal, MD
Role: primary
Hanid Audish, MD
Role: primary
Shariar Cohen-Gadol, MD
Role: primary
Dan La, MD
Role: primary
Christopher Antolini, MD
Role: primary
Eric Folkens, MD
Role: primary
Karelia Ruiz, MD
Role: primary
Ronald Surowitz, MD
Role: primary
Michael Gimness, MD
Role: primary
Juvenal Martinez, MD
Role: primary
Robert G. Perry, MD
Role: primary
Kwabena Ayesu, MD
Role: primary
Mazyar Rouhani, MD
Role: primary
Manish Jain, MD
Role: primary
Kenneth Maynard, MD
Role: primary
Hubert Reyes, MD
Role: primary
David L. Schneider, MD
Role: primary
Stephen Ong, MD
Role: primary
David DiBenedetto, MD
Role: primary
Amar Majjhoo, MD
Role: primary
Rebecca Rivard, MD
Role: primary
Jay Sandberg, MD
Role: primary
Alton Walters, MD
Role: primary
Jorge Serje, MD
Role: primary
Mary Lawrence, MD
Role: primary
Steve Choi, MD
Role: primary
Alan Kivitz, MD
Role: primary
Omer Abdullah, MD
Role: primary
Rica Santiago, MD
Role: primary
Richard Beasley, MD
Role: primary
Awilda (Michelle) Luciano, MD
Role: primary
Haresh Boghara, MD
Role: primary
Shaikh Ali, MD
Role: primary
James Clark, MD
Role: primary
Other Identifiers
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2024-520206-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
FYU-981-CRYS-301
Identifier Type: -
Identifier Source: org_study_id