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
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent. 2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following: * History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat. * Failed uricase treatment (eg, an sUA level \>6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment). 3. sUA level…