A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

Recruiting now · Phase 3

Conditions studied: Tophaceous 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 tophaceous gout.

Key facts

Study ID

NCT07089888

Run by

Crystalys Therapeutics

People needed

250

Starts

2025-08-04

Expected to finish

2027-12-31

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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
• Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter.
• sUA level ≥5.0 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 colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs).
• 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 (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.

Where it is running

• The Kirklin Clinic of University of Alabama Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
• Health Awareness Inc — Jupiter, Florida, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert — Gilbert, Arizona, 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)
• G & L Research — Foley, Alabama, United States (enrolling)
• Medvin Clinical Research - Covina — Covina, California, United States (enrolling)
• West Coast Research — Dublin, California, United States (enrolling)
• Southland Arthritis and Osteoporosis Medical Center, Inc — Menifee, California, United States (enrolling)
• Infinity Clinical Research — Norco, California, United States (enrolling)
• Amicis Research Center - Balboa — Northridge, California, United States (enrolling)
• Cure Clinical Research, LLC — Orange, 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)
• Clinical Research of Center Florida — Lakeland, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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