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
- Gout
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Crystalys Therapeutics
- Enrolment target
- 500
- Started
- 1 August 2025
- Main results due
- 29 November 2027
- Study sites
- 115
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent. 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 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. 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: 1. History of or presence of kidney stones within 1 year prior to Screening. 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 both 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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(115)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Withdrawn
G&L Research
Foley, Alabama, United States
Recruiting
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, Arizona, United States
Recruiting
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, Arizona, United States
Recruiting
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, Arizona, United States
Recruiting
Del Sol Research Management - Tucson East
Tucson, Arizona, United States
Recruiting
Medvin Clinical Research - Covina
Covina, California, United States
Recruiting
West Coast Research
Dublin, California, United States
Recruiting
Southland Arthritis and Osteoporosis Medical Center, Inc
Menifee, California, United States
Recruiting
Infinity Clinical Research
Norco, California, United States
Recruiting
Amicis Research Center - Balboa
Northridge, California, United States
Recruiting
Dream Team Clinical Research
Pomona, California, United States
Withdrawn
Velocity Clinical Research - San Bernardino
San Bernardino, California, United States
Recruiting
Acclaim Clinical Research, Inc.
San Diego, California, United States
Recruiting
East Bay Rheumatology Medical Group
San Leandro, California, United States
Recruiting
BTC Network - Encompass Clinical Research
Spring Valley, California, United States
Recruiting
Cohen Medical Centers
Thousand Oaks, California, United States
Recruiting
Medvin Clinical Research - Tujunga
Tujunga, California, United States
Recruiting
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
Recruiting
Bradenton Research Center
Bradenton, Florida, United States
Recruiting
Herco Medical and Research Center, Inc
Coral Gables, Florida, United States
Recruiting
New Generation of Medical Research
Hialeah, Florida, United States
Recruiting
Best Quality Research
Hialeah, Florida, United States
Recruiting
Health Awareness Inc
Jupiter, Florida, United States
Recruiting
Clinical Research of Center Florida
Lakeland, Florida, United States
Recruiting
Anchor Medical Research, LLC
Miami, Florida, United States
Recruiting
Panax Clinical Research
Miami Lakes, Florida, United States
Recruiting
Omega Research DeBary
Orlando, Florida, United States
Recruiting
D&H Pompano Research Center
Pompano Beach, Florida, United States
Recruiting
Clinical Research Trials of Florida
Tampa, Florida, United States
Recruiting
Conquest Research - Winter Park
Winter Park, Florida, United States
Recruiting
DelRicht Research - Atlanta
Atlanta, Georgia, United States
Withdrawn
Pediatrics & Adult Medicine/SKYCRNG
Decatur, Georgia, United States
Recruiting
SKYCRNG - Rophe Adult and Pediatric Medicine
Decatur, Georgia, United States
Recruiting
Chicago Clinical Research Institute, Inc. (CCRII)
Chicago, Illinois, United States
Recruiting
Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
Chicago, Illinois, United States
Recruiting
Healthcare Research Network - Tinley Park
Flossmoor, Illinois, United States
Recruiting
Gateway Clinical Trials
O'Fallon, Illinois, United States
Recruiting
Investigators Research Group
Brownsburg, Indiana, United States
Recruiting
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Recruiting
Delricht Research - Better Life Direct Primary Care
Indianapolis, Indiana, United States
Withdrawn
Delricht Research - Concierge And Direct Primary Care
Overland Park, Kansas, United States
Recruiting
DelRicht Research - Louisville (Derby City DPC)
Louisville, Kentucky, United States
Recruiting
Tandem Clinical Research - Metairie Clinic
Metairie, Louisiana, United States
Active, not recruiting
DelRicht Research - LCMC Health Urgent Care - Lakeview
New Orleans, Louisiana, United States
Recruiting
DelRicht Research - Prairieville
Prairieville, Louisiana, United States
Recruiting
MD Medical Research - Oxon Hill
Oxon Hill, Maryland, United States
Recruiting
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
Rockville, Maryland, United States
Withdrawn
MedVadis Research
Waltham, Massachusetts, United States
Recruiting
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, United States
Recruiting
Clinical Research Institute of Michigan - St. Clair Shores
Saint Clair Shores, Michigan, United States
Recruiting
DM Clinical Research - Detroit
Southfield, Michigan, United States
Withdrawn
Revive Research Institute - Sterling Heights
Sterling Heights, Michigan, United States
Recruiting
Oakland Medical Center
Troy, Michigan, United States
Recruiting
Healthcare Research Network
Hazelwood, Missouri, United States
Withdrawn
Delricht Research - Command Family Medicine
Springfield, Missouri, United States
Withdrawn
DelRicht Research - Town and Country
Town and Country, Missouri, United States
Recruiting
Boeson Research - Great Falls
Great Falls, Montana, United States
Recruiting
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Recruiting
Showing 60 of 115 sites — filter to narrow it down. 102 of the 115 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07089875. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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