Ireland
--:--IST
Recruiting Phase 3

A Study of Dotinurad Versus Allopurinol in Participants With Gout

NCT07089875 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2025-08-01
Last updated
2026-09-28

Condition(s) studied

Gout

Investigational drug(s) / intervention(s)

Allopurinol →Dotinurad →

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

Dotinurad: Over-encapsulated tablets containing active drug substance administered PO.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 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. 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 both 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.

Primary outcome measure(s)

  • Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 — Week 24

Trial sites (115)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Alabama Clinical Therapeutics Birmingham Alabama Withdrawn
G&L Research Foley Alabama Recruiting
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert Gilbert Arizona Recruiting
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale Glendale Arizona Recruiting
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa Mesa Arizona Recruiting
Del Sol Research Management - Tucson East Tucson Arizona Recruiting
Medvin Clinical Research - Covina Covina California Recruiting
West Coast Research Dublin California Recruiting
Southland Arthritis and Osteoporosis Medical Center, Inc Menifee California Recruiting
Infinity Clinical Research Norco California Recruiting
Amicis Research Center - Balboa Northridge California Recruiting
Dream Team Clinical Research Pomona California Withdrawn
Velocity Clinical Research - San Bernardino San Bernardino California Recruiting
Acclaim Clinical Research, Inc. San Diego California Recruiting
East Bay Rheumatology Medical Group San Leandro California Recruiting
BTC Network - Encompass Clinical Research Spring Valley California Recruiting
Cohen Medical Centers Thousand Oaks California Recruiting
Medvin Clinical Research - Tujunga Tujunga California Recruiting
Denver Arthritis Clinic - Lowry Denver Colorado Recruiting
Bradenton Research Center Bradenton Florida Recruiting
Herco Medical and Research Center, Inc Coral Gables Florida Recruiting
New Generation of Medical Research Hialeah Florida Recruiting
Best Quality Research Hialeah Florida Recruiting
Health Awareness Inc Jupiter Florida Recruiting
Clinical Research of Center Florida Lakeland Florida Recruiting
Anchor Medical Research, LLC Miami Florida Recruiting
Panax Clinical Research Miami Lakes Florida Recruiting
Omega Research DeBary Orlando Florida Recruiting
D&H Pompano Research Center Pompano Beach Florida Recruiting
Clinical Research Trials of Florida Tampa Florida Recruiting
Conquest Research - Winter Park Winter Park Florida Recruiting
DelRicht Research - Atlanta Atlanta Georgia Withdrawn
Pediatrics & Adult Medicine/SKYCRNG Decatur Georgia Recruiting
SKYCRNG - Rophe Adult and Pediatric Medicine Decatur Georgia Recruiting
Chicago Clinical Research Institute, Inc. (CCRII) Chicago Illinois Recruiting
Flourish Chicago - Ravenswood (Great Lakes Clinical Trials) Chicago Illinois Recruiting
Healthcare Research Network - Tinley Park Flossmoor Illinois Recruiting
Gateway Clinical Trials O'Fallon Illinois Recruiting
Investigators Research Group Brownsburg Indiana Recruiting

+ 75 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07089875 on ClinicalTrials.gov ↗ ← All trials in Spain