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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Dotinurad
DrugOver-encapsulated tablets containing active drug substance administered orally.
Placebo
Other interventionCapsules containing microcrystalline cellulose administered orally.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: DotinuradExperimental treatment 1 intervention
Group B: Placebo + Placebo to DotinuardExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Time frame
Week 24Secondary outcomes
1
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24
Time frame
Weeks 16, 20 and 242
Percentage of Participants With an sUA Level <6.0 <5.0, <4.0, and <3.0 mg/dL at Each Visit
Time frame
Up to Week 403
Mean Change From Baseline in sUA at Week 24
Time frame
Baseline and Week 244
Absolute Change from Baseline in sUA Levels at Each Visit
Time frame
Baseline to Week 40Sponsors and contacts
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Source ClinicalTrials.gov