A Study of Dotinurad Versus Allopurinol in Participants With Gout (NCT07089875) | Clinical Trial Compass
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
United States, Poland, Spain500 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
. 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.