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

Detailed criteria

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…

Interventions

Drug
Dotinurad
Over-encapsulated tablets containing active drug substance administered orally.
Other
Placebo
Capsules containing microcrystalline cellulose administered orally.

Locations (38)

The Kirklin Clinic of UAB Hospital
Birmingham, Alabama
Amicis Research Center
Granada Hills, California
Cohen Medical Center
Thousand Oaks, California
Solace Clinical Research
Tustin, California
Denver Arthritis Clinic - Lowry
Denver, Colorado
Omega Research Group
DeBary, Florida