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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Allopurinol
DrugOver-encapsulated tablets containing active drug substance administered orally (PO).
Dotinurad
DrugOver-encapsulated tablets containing active drug substance administered PO.
Treatment groups
500 Participants
are divided into 3 treatment groupsGroup A: AllopurinolActive comparator 1 intervention
Group B: Dotinurad 2 mg MaintenanceExperimental treatment 1 intervention
Group C: Dotinurad 4 mg MaintenanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Time frame
Week 24Secondary outcomes
1
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive
Time frame
Weeks 16, 20 and 242
Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64
Time frame
Week 36 through Week 643
Percentage of Participants With an sUA level <5.0 mg/dL at Week 24 and no Gout Flares Requiring Treatment From Week 36 Through Week 64
Time frame
Week 24 and Week 36 through Week 644
Mean Change From Baseline in sUA at Week 24
Time frame
Baseline and Week 24Sponsors and contacts
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Source ClinicalTrials.gov