Recruiting
Phase 3

Dotinurad vs. Allopurinol

Sponsor:

Crystalys Therapeutics

Code:

NCT07089875

Conditions

Gout

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Allopurinol

Dotinurad

Study Details

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.

Conditions

Gout

Study ID

NCT07089875

Start date

Aug 1, 2025

Status verified date

Aug, 2026

Completion date

Nov 29, 2027

Anticipated

Primary completion date

Nov 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Allopurinol

Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 64.

experimental: 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.

experimental: 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.

Interventions

Allopurinol

Over-encapsulated tablets containing active drug substance administered orally (PO).

Dotinurad

Over-encapsulated tablets containing active drug substance administered PO.

Primary outcome measure

  • Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Clinical Trial Lead

1-858-379-2316ClinicalTrials@crystalystx.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

G&L Research

Recruiting

Foley, Alabama, United States, 36535

Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert

Recruiting

Gilbert, Arizona, United States, 85297

Arizona Arthritis & Rheumatology Associates (AARA) - Glendale

Recruiting

Glendale, Arizona, United States, 85306

Arizona Arthritis & Rheumatology Associates (AARA) - Mesa

Recruiting

Mesa, Arizona, United States, 85110

Del Sol Research Management - Tucson East

Recruiting

Tucson, Arizona, United States, 85715

Medvin Clinical Research - Covina

Recruiting

Covina, California, United States, 91722

West Coast Research

Recruiting

Dublin, California, United States, 94568

Contacts

Tim Davis

925-413-1451tdavis@westcoastresearch.com

Principal Investigator:

Alfred Tan, MD

Southland Arthritis and Osteoporosis Medical Center, Inc

Recruiting

Menifee, California, United States, 92586

Infinity Clinical Research

Recruiting

Norco, California, United States, 92860

Amicis Research Center - Balboa

Recruiting

Northridge, California, United States, 91324

Velocity Clinical Research - San Bernardino

Recruiting

San Bernardino, California, United States, 92408

Acclaim Clinical Research, Inc.

Recruiting

San Diego, California, United States, 92120

East Bay Rheumatology Medical Group

Recruiting

San Leandro, California, United States, 94578

BTC Network - Encompass Clinical Research

Recruiting

Spring Valley, California, United States, 91978

Cohen Medical Centers

Recruiting

Thousand Oaks, California, United States, 91360-3967

Medvin Clinical Research - Tujunga

Recruiting

Tujunga, California, United States, 91042

Denver Arthritis Clinic - Lowry

Recruiting

Denver, Colorado, United States, 80230

Bradenton Research Center

Recruiting

Bradenton, Florida, United States, 34205

Herco Medical and Research Center, Inc

Recruiting

Coral Gables, Florida, United States, 33134

New Generation of Medical Research

Recruiting

Hialeah, Florida, United States, 32016

Best Quality Research

Recruiting

Hialeah, Florida, United States, 33016

Health Awareness Inc

Recruiting

Jupiter, Florida, United States, 33458

Clinical Research of Center Florida

Recruiting

Lakeland, Florida, United States, 33805

Anchor Medical Research, LLC

Recruiting

Miami, Florida, United States, 33176

Panax Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33014

Omega Research DeBary

Recruiting

Orlando, Florida, United States, 32808

D&H Pompano Research Center

Recruiting

Pompano Beach, Florida, United States, 33064

Clinical Research Trials of Florida

Recruiting

Tampa, Florida, United States, 33607

Contacts

Viviana Fonseca

813-873-8102viviana@crtfi.com

Principal Investigator:

Sady Alpizar, MD

Conquest Research - Winter Park

Recruiting

Winter Park, Florida, United States, 32789

SKYCRNG - Rophe Adult and Pediatric Medicine

Recruiting

Decatur, Georgia, United States, 30034

Chicago Clinical Research Institute, Inc. (CCRII)

Recruiting

Chicago, Illinois, United States, 60607

Principal Investigator:

Dennis Levinson, MD

Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

Recruiting

Chicago, Illinois, United States, 60640

Healthcare Research Network - Tinley Park

Recruiting

Flossmoor, Illinois, United States, 60402

Gateway Clinical Trials

Recruiting

O'Fallon, Illinois, United States, 62269

Investigators Research Group

Recruiting

Brownsburg, Indiana, United States, 46112

MediSphere Medical Research Center, LLC

Recruiting

Evansville, Indiana, United States, 47714

Delricht Research - Concierge And Direct Primary Care

Recruiting

Overland Park, Kansas, United States, 66223

DelRicht Research - Louisville (Derby City DPC)

Recruiting

Louisville, Kentucky, United States, 40205

DelRicht Research - LCMC Health Urgent Care - Lakeview

Recruiting

New Orleans, Louisiana, United States, 70124

Contacts

Emily Krambeck

504-336-2667ekrambeck@delricht.com

Principal Investigator:

Patrick Dennis, MD

DelRicht Research - Prairieville

Recruiting

Prairieville, Louisiana, United States, 70769

Contacts

Brittany Bolton

225-412-0316bbolton@delricht.com

Principal Investigator:

Taylor Sanders, MD

MD Medical Research - Oxon Hill

Recruiting

Oxon Hill, Maryland, United States, 20745

MedVadis Research

Recruiting

Waltham, Massachusetts, United States, 02451

Michigan Medicine - University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109-5000

Clinical Research Institute of Michigan - St. Clair Shores

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Revive Research Institute - Sterling Heights

Recruiting

Sterling Heights, Michigan, United States, 48313

Oakland Medical Center

Recruiting

Troy, Michigan, United States, 48085

DelRicht Research - Town and Country

Recruiting

Town and Country, Missouri, United States, 63017

Boeson Research - Great Falls

Recruiting

Great Falls, Montana, United States, 59405

Las Vegas Clinical Trials

Recruiting

North Las Vegas, Nevada, United States, 89030

Curalta Clinical Trials

Recruiting

Oradell, New Jersey, United States, 07649

Premier Health Research

Recruiting

Sparta, New Jersey, United States, 07871

Ellipsis Research Group

Recruiting

Brooklyn, New York, United States, 11215

NYU Langone Health

Recruiting

New York, New York, United States, 10016

DelRicht Research

Recruiting

Charlotte, North Carolina, United States, 28210

Carteret Medical Group LLC

Recruiting

Morehead City, North Carolina, United States, 28557

Shelby Clinical Research, LLC - North Carolina

Recruiting

Shelby, North Carolina, United States, 28150

Hometown Urgent Care and Research - Dayton

Recruiting

Dayton, Ohio, United States, 45424

Altoona Center for Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Coastal Carolina Research Center - Main

Recruiting

North Charleston, South Carolina, United States, 29405

Health Concepts

Recruiting

Rapid City, South Dakota, United States, 57702

Zenos Clinical Research

Recruiting

Dallas, Texas, United States, 75230

Lone Star Arthritis & Rheumatology Associates - Denton

Recruiting

Denton, Texas, United States, 76205

Epic Medical Research - DeSoto

Recruiting

DeSoto, Texas, United States, 75115

Prolato Clinical Research Center

Recruiting

Houston, Texas, United States, 77027

Pioneer Research Solutions

Recruiting

Houston, Texas, United States, 77099

Contacts

Mozaffari Shahin

713-333-9323shahin@pioneerresearchsolutions.com

Principal Investigator:

Francisco Velazquez, MD

R & H Clinical Research - Westborough Drive

Recruiting

Katy, Texas, United States, 77449

Alliance Clinical Lewisville (Epic Clinical Research)

Recruiting

Lewisville, Texas, United States, 75057

Southwest Rheumatology Research

Recruiting

Mesquite, Texas, United States, 75150

Discovery Clinical Trials

Recruiting

San Antonio, Texas, United States, 78229

ERG - Endeavor Clinical Trials

Recruiting

San Antonio, Texas, United States, 78240

Siena Research Network

Recruiting

Sugar Land, Texas, United States, 77479

DM Clinical Research - Tomball - Multiple Specialties

Recruiting

Tomball, Texas, United States, 77375

Digestive Health Research of North Texas

Recruiting

Wichita Falls, Texas, United States, 76301

Charlottesville Medical Research

Recruiting

Charlottesville, Virginia, United States, 22911

Gershon Pain Specialists

Recruiting

Virginia Beach, Virginia, United States, 23454

More Information

Sponsor

Crystalys Therapeutics

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • Dotinurad
  • Allopurinol
  • Hyperuricemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Crystalys Therapeutics on 2026-09-03.