A Study of Dotinurad Versus Allopurinol in Participants With Gout
Key facts
- Where
- Bialystok, Białystok, Cracow, Gdynia, Katowice, Plonsk, Poznan, Sochaczew, Warsaw, Wejherowo, and Wroclaw, PolandSee the 13 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07089875, who can take part
Where in Poland
- Clinicmed Daniluk Nowak Sp. k.Bialystok, PolandTaking people
- INTER CLINIC Piotr Adrian KlimiukBiałystok, PolandTaking people
- Futuremeds Sp. z o.o.Cracow, PolandTaking people
- FutureMeds Sp. z o.o.Gdynia, PolandTaking people
- Pro Familia Altera Sp. z o.o.Katowice, PolandTaking people
- Silmedic Sp. z o.o.Katowice, PolandTaking people
- Innova Clinic Sp. z o.o.Plonsk, PolandTaking people
- Solumed Centrum Medyczne Sp. z o.o.Poznan, PolandTaking people
- RCMed Oddzial SochaczewSochaczew, PolandTaking people
- Futuremeds Sp. z o.o.Warsaw, PolandTaking people
- Medicover Integrated Clinical Services Sp. z o.o.Warsaw, PolandTaking people
- Med-Progress Osrodek Nowoczesnego Leczenia Sp. z o.o.Wejherowo, PolandTaking people
- Futuremeds Sp. z o.o.Wroclaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Crystalys Therapeutics
- Trial code
- NCT07089875EU 2024-520206-19-00
- Record updated
- 12 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.