A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
- Registration Number
- NCT07089888
- Lead Sponsor
- Crystalys Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Allopurinol Allopurinol Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 76. Dotinurad Dotinurad Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4), dotinurad 2 mg QD for the next 8 weeks (Weeks 5-12), and dotinurad 4 mg QD thereafter up through Week 76.
- Primary Outcome Measures
Name Time Method Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24 Week 24
- Secondary Outcome Measures
Name Time Method Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76 Week 76 Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76 Week 76 Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24 Week 24 Mean Rate of Gout Flares Requiring Treatment from Week 36 Through Week 76 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 Week 24 and Week 36 through Week 76 Mean Change from Baseline in sUA at Week 24 Baseline and Week 24 Mean Percent Change from Baseline in the Sum of the Areas for all Target Tophi at Each Visit Baseline to Week 80 Percentage of Participants who Do Not have a Gout Flare Requiring Treatment from Week 36 through Week 76 Week 36 through Week 76 Percentage of Participants with an sUA Level <5.0 mg/dL at Each Visit Up to Week 80 Percentage of Participants with an sUA Level <4.0 mg/dL at Each Visit Up to Week 80 Percentage of Participants with an sUA Level <3.0 mg/dL at Each Visit Up to Week 80 Absolute Change from Baseline in sUA Levels at Each Visit Baseline to Week 80 Percent Change from Baseline in sUA Levels at Each Visit Baseline to Week 80 Percentage of Participants with a Gout Flare Requiring Treatment at Each Month Between Week 24 and the End of Study Week 24 to Week 80 Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Up to Week 80 Percentage of Participants with Serious Adverse Events (SAEs) Up to Week 80
Trial Locations
- Locations (24)
Acclaim Clinical Research, Inc.
🇺🇸San Diego, California, United States
Herco Medical and Research Center, Inc
🇺🇸Coral Gables, Florida, United States
Best Quality Research
🇺🇸Hialeah, Florida, United States
DelRicht Research - Atlanta
🇺🇸Atlanta, Georgia, United States
Delricht Research - Better Life Direct Primary Care
🇺🇸Indianapolis, Indiana, United States
Delricht Research - Concierge And Direct Primary Care
🇺🇸Overland Park, Kansas, United States
DelRicht Research - Louisville (Derby City DPC)
🇺🇸Louisville, Kentucky, United States
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
🇺🇸Rockville, Maryland, United States
Delricht Research - Command Family Medicine
🇺🇸Springfield, Missouri, United States
DelRicht Research - Town and Country
🇺🇸Town and Country, Missouri, United States
Scroll for more (14 remaining)Acclaim Clinical Research, Inc.🇺🇸San Diego, California, United StatesJohn Beckes, MDPrincipal Investigator