Recruiting

Phase 3

Dotinurad vs. AllopurinolA Study of Dotinurad Versus Allopurinol in Tophaceous Gout

Sponsor:

Crystalys Therapeutics

Code:

NCT07089888

Conditions

Tophaceous 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 tophaceous gout.

Conditions

Tophaceous Gout

Study ID

NCT07089888

Start date

Aug 4, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
3. 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.
4. sUA level ≥5.0 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
5. 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.
6. 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 colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs).
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 (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.

Study Design

Enrollment

250 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 76.

experimental: Dotinurad

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 up through Week 76.

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 <5.0 mg/dL at Week 24 [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Clinical Trial Lead

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

Locations

The Kirklin Clinic of University of Alabama Birmingham Hospital

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, 85210

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

925-413-1451 tdavis@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

Cure Clinical Research, LLC

Recruiting

Orange, California, United States, 92866

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

D&H Pompano Research Center

Recruiting

Margate, Florida, United States, 33063

Well Pharma Medical Research

Recruiting

Miami, Florida, United States, 33173

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

Clinical Research Trials of Florida

Recruiting

Tampa, Florida, United States, 33607

Contacts

Viviana Fonseca

813-873-8102 viviana@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

Contacts

Manognya Sama

312-791-3241 manognya@ccrii.us

Principal Investigator:

Dennis Levinson, MD

Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

Recruiting

Chicago, Illinois, United States, 60640

Gateway Clinical Trials

Recruiting

O'Fallon, Illinois, United States, 62269

MediSphere Medical Research Center, LLC - East

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

504-336-2667 ekrambeck@delricht.com

Principal Investigator:

Patrick Dennis, MD

DelRicht Research - Prairieville

Recruiting

Prairieville, Louisiana, United States, 70769

Contacts

Brittany Bolton

225-412-0316 bbolton@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

A. Alfred Taubman Health Care Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Clinical Research Institute of Michigan - St. Clair Shores

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Revival 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

Sahni Rheumatology & Therapy

Recruiting

West Long Branch, New Jersey, United States, 07764

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

Triad Clinical Trials

Recruiting

Greensboro, North Carolina, United States, 27410

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

Preferred Primary Care Physicians - Matthew Drive

Recruiting

Uniontown, Pennsylvania, United States, 15401

Coastal Carolina Research Center - Main

Recruiting

North Charleston, South Carolina, United States, 29405

Health Concepts

Recruiting

Rapid City, South Dakota, United States, 57702

Arthritis & Osteoporosis Center of Coastal Bend

Recruiting

Corpus Christi, Texas, United States, 78415

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

Pioneeer Research Solutions

Recruiting

Houston, Texas, United States, 77099

Contacts

Mozaffari Shahin

713-333-9323 shahin@pioneerresearchsolutions.com

Principal Investigator:

Francisco Velazquez, MD

Epic Medical Research - Hurst

Recruiting

Hurst, Texas, United States, 76054

R & H Clinical Research - South Fry Road

Recruiting

Katy, Texas, United States, 77450

Premise Clinical Research Center

Recruiting

Lancaster, Texas, United States, 75146

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

Epic Medical Research - San Marcos

Recruiting

San Marcos, Texas, United States, 78666

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

Rio Clinical Trials - Corporate Office

Recruiting

Ogden, Utah, United States, 84404

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

Tophaceous Gout
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.