A Study of Dotinurad Versus Allopurinol in Participants With Gout

Recruiting now · Phase 3

Conditions studied: Gout

In brief

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.

Key facts

Study ID

NCT07089875

Run by

Crystalys Therapeutics

People needed

500

Starts

2025-08-01

Expected to finish

2027-11-29

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
• Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year.
• 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).
• 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.
• sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
• 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.
• 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.

You may not qualify if…

• History of or presence of kidney stones within 1 year prior to Screening.
• History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
• Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs.
• Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
• Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.
• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Anchor Medical Research, LLC — Miami, Florida, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates (AARA) - Glendale — Glendale, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates (AARA) - Mesa — Mesa, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert — Gilbert, Arizona, United States (enrolling)
• Del Sol Research Management - Tucson — Tucson, Arizona, United States (enrolling)
• Medvin Clinical Research - Covina — Covina, California, United States (enrolling)
• West Coast Research — Dublin, California, United States (enrolling)
• Infinity Clinical Research — Norco, California, United States (enrolling)
• Amicis Research Center - Balboa — Northridge, California, United States (enrolling)
• Del Sol Research Management - Tucson East — Tucson, Arizona, United States (enrolling)
• Velocity Clinical Research - San Bernardino — San Bernardino, California, United States (enrolling)
• Acclaim Clinical Research, Inc. — San Diego, California, United States (enrolling)
• East Bay Rheumatology Medical Group — San Leandro, California, United States (enrolling)
• BTC Network - Encompass Clinical Research — Spring Valley, California, United States (enrolling)
• Cohen Medical Centers — Thousand Oaks, California, United States (enrolling)
• Medvin Clinical Research - Tujunga — Tujunga, California, United States (enrolling)
• Denver Arthritis Clinic - Lowry — Denver, Colorado, United States (enrolling)
• Bradenton Research Center — Bradenton, Florida, United States (enrolling)
• Herco Medical and Research Center, Inc — Coral Gables, Florida, United States (enrolling)
• New Generation of Medical Research — Hialeah, Florida, United States (enrolling)
• Best Quality Research — Hialeah, Florida, United States (enrolling)
• Health Awareness Inc — Jupiter, Florida, United States (enrolling)
• Clinical Research of Center Florida — Lakeland, Florida, United States (enrolling)
• Panax Clinical Research — Miami Lakes, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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