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NCT07089875PHASE3Recruiting

A Study of Dotinurad Versus Allopurinol in Participants With Gout

Crystalys Therapeutics

Start Date

8/1/2025

Completion Date

11/29/2027

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Allopurinol

DRUG

Dotinurad

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Conditions

Gout

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Alabama Clinical Therapeutics

Birmingham, Alabama 35235

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 85110

United States

Del Sol Research Management - Tucson East

Tucson, Arizona 85715

United States

Del Sol Research Management - Tucson

Tucson, Arizona 85715

United States

Medvin Clinical Research - Covina

Covina, California 91722

United States

West Coast Research

Dublin, California 94568

United States

Infinity Clinical Research

Norco, California 92860

United States

Amicis Research Center - Balboa

Northridge, California 91324

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

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

D&H Pompano Research Center

Pompano Beach, Florida 33064

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

Chicago Clinical Research Institute, Inc. (CCRII)

Chicago, Illinois 60607

United States

Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

Chicago, Illinois 60640

United States

Healthcare Research Network - Tinley Park

Flossmoor, Illinois 60402

United States

Investigators Research Group

Brownsburg, Indiana 46112

United States

MediSphere Medical Research Center, LLC

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

Michigan Medicine - University of Michigan

Ann Arbor, Michigan 48109-5000

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

Revive Research Institute - Sterling Heights

Sterling Heights, Michigan 48313

United States

Oakland Medical Center

Troy, Michigan 48085

United States

Healthcare Research Network

Hazelwood, Missouri 63042

United States

Delricht Research - Command Family Medicine

Springfield, Missouri 65807

United States

DelRicht Research - Town and Country

Town and Country, Missouri 63017

United States

Las Vegas Clinical Trials

North Las Vegas, Nevada 89030

United States

Premier Health Research

Sparta, New Jersey 07871

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

Carteret Medical Group LLC

Morehead City, North Carolina 28557

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

Altoona Center for Clinical Research

Duncansville, Pennsylvania 16635

United States

Suburban Research Associates - West Chester Office

West Chester, Pennsylvania 19380

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

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

Pioneer Research Solutions

Houston, Texas 77099

United States

R & H Clinical Research - Westborough Drive

Katy, Texas 77449

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

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

Charlottesville Medical Research

Charlottesville, Virginia 22911

United States

Centrum Medyczne Solumed

Poznan, Greater Poland Voivodeship 60-529

Poland

FutureMeds - Krakow

Krakow, Lesser Poland Voivodeship 31-501

Poland

FutureMeds - Wroclaw

Wroclaw, Lower Silesian Voivodeship 53-673

Poland

Innova Clinic

Plońsk, Masovian Voivodeship 09-100

Poland

Prolato Clinical Research Center

Sochaczew, Masovian Voivodeship 96-500

Poland

Medicover Integrated Clinical Services- MICS Centrum Medyczne Warszawa Chlodna

Warsaw, Masovian Voivodeship 00-872

Poland

FutureMeds - Targówek

Warsaw, Masovian Voivodeship 03-291

Poland

Inter Clinic

Bialystok, Podlaskie Voivodeship 15-077

Poland

ClinicMed Daniluk, Nowak Spółka Komandytowa

Bialystok, Podlaskie Voivodeship 15-879

Poland

FutureMeds Gdynia

Gdynia, Pomeranian Voivodeship 81-537

Poland

Med-Progress Ośrodek Nowoczesnego Leczenia

Wejherowo, Pomeranian Voivodeship 84-200

Poland

Pro Familia - Katowice

Katowice, Silesian Voivodeship 40-122

Poland

Silmedic sp. z o.o.

Katowice, Silesian Voivodeship 40-282

Poland

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña 15006

Spain

Clínica Gaias Santiago

Santiago de Compostela, La Coruña 15706

Spain

Accellacare - Alcobendas

Alcobendas, Madrid 28100

Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid 28032

Spain

Hospital Quirónsalud Infanta Luisa

Seville, Sevilla 41010

Spain

Clínica NTDE - Nuevas Tecnologías en Diabetes y Endocrinología

Seville, Sevilla 46010

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain