The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Time frame: Week 24
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24
Time frame: Weeks 16, 20 and 24
Percentage of Participants With an sUA Level <6.0 <5.0, <4.0, and <3.0 mg/dL at Each Visit
Time frame: Up to Week 40
Mean Change From Baseline in sUA at Week 24
Time frame: Baseline and Week 24
Absolute Change from Baseline in sUA Levels at Each Visit
Time frame: Baseline to Week 40
Percent Change from Baseline in sUA Levels at Each Visit
Time frame: Baseline to Week 40
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Treatment Periods 1 and 2
Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion.
Time frame: Screening to Week 36
Number of Participants With TEAEs and SAEs Throughout the Study
Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion.
Time frame: Screening to Week 40
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