A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
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
Other study identifiers
Sponsor study identifier
Secondary identifiers
CTIS
interventional
250
1 country
96
Study Start
August 4, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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 tophaceous gout.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- recruiting
- Estimated enrollment
- 250 participants
- Study completion date
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 1 countries · 96 sites
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
July 22, 2025
Actual (reported)First Posted
July 28, 2025
Actual (reported)Study Start
August 4, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- October 29, 2026
- Status Verified
- October 2026
- Last Update Submitted
- October 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24
Week 24
Secondary Outcomes (16)
Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76
Week 76
Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76
Week 76
Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24
Week 24
Mean Rate of Gout Flares Requiring Treatment from 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
Week 24 and Week 36 through Week 76
- +11 more secondary outcomes
Study Arms (2)
Allopurinol
ACTIVE COMPARATORParticipants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 76.
Dotinurad
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 up through Week 76.
Interventions
Over-encapsulated tablets containing active drug substance administered orally (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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
- 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.
- sUA level ≥5.0 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 (NSAIDs).
- 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 (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Crystalys TherapeuticsIndustrylead
Study Sites (96)
The Kirklin Clinic of University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
G & L Research
Foley, Alabama, 36535, 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, 85210, United States
Del Sol Research Management - Tucson East
Tucson, Arizona, 85715, United States
Medvin Clinical Research - Covina
Covina, California, 91722, United States
West Coast Research
Dublin, California, 94568, United States
Southland Arthritis and Osteoporosis Medical Center, Inc
Menifee, California, 92586, United States
Infinity Clinical Research
Norco, California, 92860, United States
Amicis Research Center - Balboa
Northridge, California, 91324, United States
Cure Clinical Research, LLC
Orange, California, 92866, 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
D&H Pompano Research Center
Margate, Florida, 33063, United States
Well Pharma Medical Research
Miami, Florida, 33173, 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
Clinical Research Trials of Florida
Tampa, Florida, 33607, United States
Conquest Research - Winter Park
Winter Park, Florida, 32789, United States
DelRicht Research - Atlanta
Atlanta, Georgia, 30329, United States
Pediatrics & Adult Medicine/SKYCRNG
Decatur, Georgia, 30034, United States
SKYCRNG - Rophe Adult and Pediatric Medicine
Decatur, Georgia, 30034, 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
Gateway Clinical Trials
O'Fallon, Illinois, 62269, United States
MediSphere Medical Research Center, LLC - East
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
A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109, 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
Revival Research Institute - Sterling Heights
Sterling Heights, Michigan, 48313, United States
Oakland Medical Center
Troy, Michigan, 48085, United States
Delricht Research - Command Family Medicine
Springfield, Missouri, 65807, United States
DelRicht Research - Town and Country
Town and Country, Missouri, 63017, United States
Boeson Research - Great Falls
Great Falls, Montana, 59405, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
Curalta Clinical Trials
Oradell, New Jersey, 07649, United States
Premier Health Research
Sparta, New Jersey, 07871, United States
Sahni Rheumatology & Therapy
West Long Branch, New Jersey, 07764, United States
Ellipsis Research Group
Brooklyn, New York, 11215, United States
NYU Langone Health
New York, New York, 10016, United States
DelRicht Research
Charlotte, North Carolina, 28210, United States
Triad Clinical Trials
Greensboro, North Carolina, 27410, 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
Preferred Primary Care Physicians - Matthew Drive
Uniontown, Pennsylvania, 15401, United States
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, 19380, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090, 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
Arthritis & Osteoporosis Center of Coastal Bend
Corpus Christi, Texas, 78415, 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
Pioneeer Research Solutions
Houston, Texas, 77099, United States
Epic Medical Research - Hurst
Hurst, Texas, 76054, United States
R & H Clinical Research - South Fry Road
Katy, Texas, 77450, United States
Premise Clinical Research Center
Lancaster, Texas, 75146, 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
Epic Medical Research - San Marcos
San Marcos, Texas, 78666, United States
Siena Research Network
Sugar Land, Texas, 77479, United States
DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas, 77375, United States
Digestive Health Research of North Texas
Wichita Falls, Texas, 76301, United States
Ogden Clinic Canyon View/RIO Clinical Trials
Ogden, Utah, 84404, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Gershon Pain Specialists
Virginia Beach, Virginia, 23454, United States
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 4, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
Individual participant data that underlie the results reported for publication, after deidentification.
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- NCT07089888
- Data provider
- ClinicalTrials.gov
- Source updated
- 2026-10-29
- Normalization version
- ctgov-2
Source retrieved: