Gout
Conditions
Keywords
Dotinurad, Xanthine Oxidase Inhibitors
Brief 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.
Interventions
DRUGDotinurad
Over-encapsulated tablets containing active drug substance administered orally.
OTHERPlacebo
Capsules containing microcrystalline cellulose administered orally.
Sponsors
Crystalys Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 \>6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit). 4. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding. 5. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of trial drug.
Exclusion criteria
1. History of or presence of kidney stones within 1 year prior to Screening. 2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma. 3. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse. 4. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening. 5. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 | Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 | Weeks 16, 20 and 24 | — |
| Percentage of Participants With an sUA Level <6.0 <5.0, <4.0, and <3.0 mg/dL at Each Visit | Up to Week 40 | — |
| Mean Change From Baseline in sUA at Week 24 | Baseline and Week 24 | — |
| Absolute Change from Baseline in sUA Levels at Each Visit | Baseline to Week 40 | — |
| Percent Change from Baseline in sUA Levels at Each Visit | Baseline to Week 40 | — |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Treatment Periods 1 and 2 | Screening to Week 36 | Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion. |
| Number of Participants With TEAEs and SAEs Throughout the Study | Screening to Week 40 | Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion. |
Countries
United States
Contacts
CONTACTClinical Trial Lead
Outcome results
None listed