A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
ConditionGout
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCrystalys Therapeutics
About this trial
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
Qualifiers
Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
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).
sUA level >6.0 and <10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).
Disqualifiers
History of or presence of kidney stones within 1 year prior to Screening.
History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening.
Trial design
Treatments tested in this trial
- Dotinurad
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsLocations
17California
Amicis Research Center91344, Granada Hills United States
Cohen Medical Center91360, Thousand Oaks United States
Florida
Omega Research Group32713, DeBary United States
Clinical Research of Central Florida33805, Lakeland United States
Sponsors and collaborators
Crystalys Therapeutics
Lead sponsor
Source ClinicalTrials.gov