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RECRUITING

NCT07089875

PHASE3

A Study of Dotinurad Versus Allopurinol in Participants With Gout

Sponsor: Crystalys Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2025-08-01

Completion Date

2027-11-29

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Gout

Interventions

DRUG

Allopurinol

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

DRUG

Dotinurad

Over-encapsulated tablets containing active drug substance administered PO.

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) 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 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.

Locations (95)

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

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

Clinical Research Institute of Michigan - St. Clair Shores

Saint Clair Shores, Michigan, United States

DM Clinical Research - Detroit

Southfield, 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

New York University Langone Orthopedic Center

New York, New York, United States

DelRicht Research - Charlotte (Direct Primary Care - DPC)

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

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

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