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NCT07535034
A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
Conditions: Gout
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 90
Sponsor: Crystalys Therapeutics
Location: The Kirklin Clinic of UAB Hospital Birmingham Alabama
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 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 \>6.0 and \
Source: ClinicalTrials.gov (NCT07535034). StuddyBuddy aggregates publicly available trial information.
