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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
Over-encapsulated tablets containing active drug substance administered orally (PO).
Over-encapsulated tablets containing active drug substance administered PO.
Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24
Time frame: Week 24
Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76
Time frame: Week 76
Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76
Time frame: Week 76
Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24
Time frame: Week 24
Mean Rate of Gout Flares Requiring Treatment from Week 36 Through Week 76
Time frame: Week 36 through Week 76
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 76
Time frame: Week 24 and Week 36 through Week 76
Mean Change from Baseline in sUA at Week 24
Time frame: Baseline and Week 24
Mean Percent Change from Baseline in the Sum of the Areas for all Target Tophi at Each Visit
Time frame: Baseline to Week 80
Percentage of Participants who Do Not have a Gout Flare Requiring Treatment from Week 36 through Week 76
Time frame: Week 36 through Week 76
Percentage of Participants with an sUA Level <5.0 mg/dL at Each Visit
Time frame: Up to Week 80
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
RECRUITINGArizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, Arizona, United States
RECRUITINGArizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, Arizona, United States
RECRUITINGArizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, Arizona, United States
RECRUITINGDel Sol Research Management - Tucson East
Tucson, Arizona, United States
RECRUITINGMedvin Clinical Research - Covina
Covina, California, United States
RECRUITINGWest Coast Research
Dublin, California, United States
RECRUITINGInfinity Clinical Research
Norco, California, United States
RECRUITINGAmicis Research Center - Balboa
Northridge, California, United States
RECRUITINGDream Team Clinical Research
Pomona, California, United States
RECRUITING...and 58 more locations
Percentage of Participants with an sUA Level <4.0 mg/dL at Each Visit
Time frame: Up to Week 80
Percentage of Participants with an sUA Level <3.0 mg/dL at Each Visit
Time frame: Up to Week 80
Absolute Change from Baseline in sUA Levels at Each Visit
Time frame: Baseline to Week 80
Percent Change from Baseline in sUA Levels at Each Visit
Time frame: Baseline to Week 80
Percentage of Participants with a Gout Flare Requiring Treatment at Each Month Between Week 24 and the End of Study
Time frame: Week 24 to Week 80
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 80
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Week 80