A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
ConditionTophaceous Gout
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 tophaceous 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-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).
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 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.
Trial design
Treatments tested in this trial
- Allopurinol
- Dotinurad
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov