Recruiting NCT07535034
A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dotinurad, Placebo.
- Who it may be relevant to
- Registry conditions: Gout. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Dotinurad
Over-encapsulated tablets containing active drug substance administered orally. - Other Placebo
Capsules containing microcrystalline cellulose administered orally.
Primary outcome measures
- Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 [Time frame: Week 24]
Secondary outcome measures (7)
- Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 [Time frame: 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 [Time frame: Up to Week 40]
- Mean Change From Baseline in sUA at Week 24 [Time frame: Baseline and Week 24]
- Absolute Change from Baseline in sUA Levels at Each Visit [Time frame: Baseline to Week 40]
- Percent Change from Baseline in sUA Levels at Each Visit [Time frame: Baseline to Week 40]
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Treatment Periods 1 and 2 [Time frame: Screening to Week 36]
- Number of Participants With TEAEs and SAEs Throughout the Study [Time frame: Screening to Week 40]
Eligibility criteria
Inclusion criteria
- Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- 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).
- sUA level >6.0 and <10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).
- 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.
- 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
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 29 centers
- Amicis Research Center — Granada Hills
- Cohen Medical Center — Thousand Oaks
- Solace Clinical Research — Tustin
- Denver Arthritis Clinic - Lowry — Denver
- Omega Research Group — DeBary
- Herco Medical and Research Center, Inc — Flagami
- New Generation of Medical Research — Hialeah
- Health Awareness, Inc. — Jupiter
- … and 21 more centers
Identifiers
NCT: NCT07535034 · FYU-981-CRYS-201