RecruitingPhase 3NCT07089875

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

Sponsor

Crystalys Therapeutics

Enrollment

500 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Gout

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Allopurinol and a drug called Dotinurad for people with gout. The study is currently recruiting participants at 100 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAllopurinol

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

DRUGDotinurad

Over-encapsulated tablets containing active drug substance administered PO.

Locations(100)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert

Gilbert, Arizona, United States

Arizona Arthritis & Rheumatology Associates (AARA) - Glendale

Glendale, Arizona, United States

Arizona Arthritis & Rheumatology Associates (AARA) - Mesa

Mesa, Arizona, United States

Del Sol Research Management - Tucson East

Tucson, Arizona, United States

Del Sol Research Management - Tucson

Tucson, Arizona, United States

Medvin Clinical Research - Covina

Covina, California, United States

West Coast Research

Dublin, California, United States

Infinity Clinical Research

Norco, California, United States

Amicis Research Center - Balboa

Northridge, California, United States

Dream Team Clinical Research

Pomona, California, United States

Velocity Clinical Research - San Bernardino

San Bernardino, California, United States

Acclaim Clinical Research, Inc.

San Diego, California, United States

East Bay Rheumatology Medical Group

San Leandro, California, United States

BTC Network - Encompass Clinical Research

Spring Valley, California, United States

Cohen Medical Centers

Thousand Oaks, California, United States

Medvin Clinical Research - Tujunga

Tujunga, California, United States

Denver Arthritis Clinic - Lowry

Denver, Colorado, United States

Bradenton Research Center

Bradenton, Florida, United States

Herco Medical and Research Center, Inc

Coral Gables, Florida, United States

New Generation of Medical Research

Hialeah, Florida, United States

Best Quality Research

Hialeah, Florida, United States

Health Awareness Inc

Jupiter, Florida, United States

Clinical Research of Center Florida

Lakeland, Florida, United States

Anchor Medical Research, LLC

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Omega Research DeBary

Orlando, Florida, United States

D&H Pompano Research Center

Pompano Beach, Florida, United States

Clinical Research Trials of Florida

Tampa, Florida, United States

Conquest Research - Winter Park

Winter Park, Florida, United States

DelRicht Research - Atlanta

Atlanta, Georgia, United States

Chicago Clinical Research Institute, Inc. (CCRII)

Chicago, Illinois, United States

Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

Chicago, Illinois, United States

Healthcare Research Network - Tinley Park

Flossmoor, Illinois, United States

Investigators Research Group

Brownsburg, Indiana, United States

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

Delricht Research - Better Life Direct Primary Care

Indianapolis, Indiana, United States

Delricht Research - Concierge And Direct Primary Care

Overland Park, Kansas, United States

DelRicht Research - Louisville (Derby City DPC)

Louisville, Kentucky, United States

Tandem Clinical Research - Metairie Clinic

Metairie, Louisiana, United States

DelRicht Research - LCMC Health Urgent Care - Lakeview

New Orleans, Louisiana, United States

DelRicht Research - Prairieville

Prairieville, Louisiana, United States

MD Medical Research - Oxon Hill

Oxon Hill, Maryland, United States

DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)

Rockville, Maryland, United States

MedVadis Research

Waltham, Massachusetts, United States

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan - St. Clair Shores

Saint Clair Shores, Michigan, United States

DM Clinical Research - Detroit

Southfield, Michigan, United States

Revive Research Institute - Sterling Heights

Sterling Heights, Michigan, United States

Oakland Medical Center

Troy, Michigan, United States

Healthcare Research Network

Hazelwood, Missouri, United States

Delricht Research - Command Family Medicine

Springfield, Missouri, United States

DelRicht Research - Town and Country

Town and Country, Missouri, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Ellipsis Research Group

Brooklyn, New York, United States

NYU Langone Health

New York, New York, United States

DelRicht Research

Charlotte, North Carolina, United States

Carteret Medical Group LLC

Morehead City, North Carolina, United States

Shelby Clinical Research, LLC - North Carolina

Shelby, North Carolina, United States

Hometown Urgent Care and Research - Dayton

Dayton, Ohio, United States

Delricht Research - Concierge Medicine Of Cincinnati

Mason, Ohio, United States

DelRicht Research - Tulsa

Tulsa, Oklahoma, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Suburban Research Associates - West Chester Office

West Chester, Pennsylvania, United States

Coastal Carolina Research Center - Main

North Charleston, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

DelRicht Research - Hendersonville

Hendersonville, Tennessee, United States

Zenos Clinical Research

Dallas, Texas, United States

Lone Star Arthritis & Rheumatology Associates - Denton

Denton, Texas, United States

Epic Medical Research - DeSoto

DeSoto, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

Pioneer Research Solutions

Houston, Texas, United States

R & H Clinical Research - Westborough Drive

Katy, Texas, United States

Alliance Clinical Lewisville (Epic Clinical Research)

Lewisville, Texas, United States

Southwest Rheumatology Research

Mesquite, Texas, United States

Discovery Clinical Trials

San Antonio, Texas, United States

ERG - Endeavor Clinical Trials

San Antonio, Texas, United States

DM Clinical Research - Tomball - Multiple Specialties

Tomball, Texas, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Centrum Medyczne Solumed

Poznan, Greater Poland Voivodeship, Poland

FutureMeds - Krakow

Krakow, Lesser Poland Voivodeship, Poland

FutureMeds - Wroclaw

Wroclaw, Lower Silesian Voivodeship, Poland

Innova Clinic

Plońsk, Masovian Voivodeship, Poland

Prolato Clinical Research Center

Sochaczew, Masovian Voivodeship, Poland

Medicover Integrated Clinical Services- MICS Centrum Medyczne Warszawa Chlodna

Warsaw, Masovian Voivodeship, Poland

FutureMeds - Targówek

Warsaw, Masovian Voivodeship, Poland

Inter Clinic

Bialystok, Podlaskie Voivodeship, Poland

ClinicMed Daniluk, Nowak Spółka Komandytowa

Bialystok, Podlaskie Voivodeship, Poland

FutureMeds Gdynia

Gdynia, Pomeranian Voivodeship, Poland

Med-Progress Ośrodek Nowoczesnego Leczenia

Wejherowo, Pomeranian Voivodeship, Poland

Pro Familia - Katowice

Katowice, Silesian Voivodeship, Poland

Silmedic sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Clínica Gaias Santiago

Santiago de Compostela, La Coruña, Spain

Accellacare - Alcobendas

Alcobendas, Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid, Spain

Hospital Quirónsalud Infanta Luisa

Seville, Sevilla, Spain

Clínica NTDE - Nuevas Tecnologías en Diabetes y Endocrinología

Seville, Sevilla, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

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NCT07089875

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