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A Study of Dotinurad Versus Allopurinol in Participants With Gout | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT07089875•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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

August 1, 2025

Primary Completion Date

November 29, 2027

Completion Date

November 29, 2027

Last Updated

March 12, 2026

Enrollment

500

ESTIMATED participants

Conditions

Gout

Interventions

Allopurinol

DRUG

Dotinurad

DRUG

Contacts

Clinical Trial Lead

CONTACT

(858) 356-4740 ClinicalTrials@crystalystx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Dotinurad Versus Allopurinol in Participants With Gout

Inclusion Criteria

Exclusion Criteria

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