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A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
Sponsor: Crystalys Therapeutics
Summary
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.
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-05-08
Completion Date
2027-08
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
Dotinurad
Over-encapsulated tablets containing active drug substance administered orally.
Placebo
Capsules containing microcrystalline cellulose administered orally.
Locations (29)
Amicis Research Center
Granada Hills, California, United States
Cohen Medical Center
Thousand Oaks, California, United States
Solace Clinical Research
Tustin, California, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
Omega Research Group
DeBary, Florida, United States
Herco Medical and Research Center, Inc
Flagami, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Clinical Research of Central Florida
Lakeland, Florida, United States
D&H Pompano Research Center, LLC
Margate, Florida, United States
Panax Clinical Research
Miami, Florida, United States
Anchor Medical Research
Miami, Florida, United States
MD Medical Research
Oxon Hill, Maryland, United States
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, United States
Revival Research Institute
Sterling Heights, Michigan, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
Premier Health Research
Sparta, New Jersey, United States
Ellipsis Research Group
Brooklyn, New York, United States
Drug Trials America
Hartsdale, New York, United States
Shelby Clinical Research
Shelby, North Carolina, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Zenos Clinical Research
Dallas, Texas, United States
Epic Medical Research
DeSoto, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
R&H Clinical Research - Westborough Drive
Katy, Texas, United States
Southwest Rheumatology Research
Mesquite, Texas, United States
Discovery Clinical Trials, LLC
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Digestive Health Research of North Texas
Wichita Falls, Texas, United States