A Study of Dotinurad Versus Allopurinol in Participants With Gout
ConditionGout
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCrystalys Therapeutics
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Allopurinol
- Dotinurad
Treatment groups
500 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov