Actively Recruiting
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate Dotinurad in Adults With Gout Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment
Led by Crystalys Therapeutics · Updated on 2026-05-22
90
Participants Needed
8
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of dotinurad in reducing serum uric acid levels in adults with gout who cannot tolerate xanthine oxidase inhibitors (XOI) or who have not responded to uricase treatment. This Phase 2, randomized, double-blind, placebo-controlled study aims to better understand dotinurad's role in managing gout, particularly in those with previous treatment challenges. The study is sponsored by Crystalys Therapeutics and focuses on participants aged 18 to 75 years with a diagnosis of gout meeting specific criteria. Participants will be randomly assigned to one of two groups. One group will take dotinurad for 24 weeks, followed by an additional 12 weeks continuing dotinurad. The other group will receive a placebo for 24 weeks, then switch to dotinurad for the next 12 weeks. Dotinurad is given as oral over-encapsulated tablets, while the placebo contains inactive capsules. This two-part treatment period is designed to assess the drug's efficacy and safety over time. During the study, participants will have their serum uric acid levels measured at various points, including weeks 16, 20, 24, and up to week 40. Researchers will monitor the percentage of participants achieving specific uric acid level targets, changes from baseline, and any treatment-emergent or serious adverse events. The total study duration includes screening, treatment, and follow-up periods, allowing comprehensive evaluation of dotinurad's effects and safety profile in this population.
CONDITIONS
Brief Title
A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- Diagnosis of gout based on 2015 ACR-EULAR criteria for at least 1 year.
- History of intolerance or contraindication to allopurinol or febuxostat, or failed uricase treatment with sUA >6.0 mg/dL at least 2 weeks after last infusion.
- Serum uric acid level >6.0 and <10.5 mg/dL at both screening visits.
- Female participants of childbearing potential must have negative pregnancy tests and not be breastfeeding.
- Fertile male participants and females of childbearing potential must agree to abstain from heterosexual sex or use acceptable contraception from consent through 30 days after last dose.
You will not qualify if you...
- History or presence of kidney stones within 1 year prior to screening.
- History or presence of malignancy in the last 5 years, except treated basal or squamous cell carcinoma.
- Known or suspected drug abuse, positive drug test at screening, or recent alcohol abuse.
- Known history of or positive tests for HIV, Hepatitis B surface antigen, or Hepatitis C during screening.
- Any clinically significant disease or condition that may compromise safety, trial compliance, or confound results as judged by the Investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 weeks
Participants receive oral doses of dotinurad or placebo during two consecutive treatment periods.
Visits at baseline and periodic visits through Week 40
Trial Site Locations
Total: 8 locations
1
Amicis Research Center
Granada Hills, California, United States, 91344
Actively Recruiting
2
Cohen Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
3
Panax Clinical Research
Miami, Florida, United States, 33014
Actively Recruiting
4
Anchor Medical Research
Miami, Florida, United States, 33176
Actively Recruiting
5
Las Vegas Clinical Trials
Las Vegas, Nevada, United States, 89030
Actively Recruiting
6
Ellipsis Research Group
Brooklyn, New York, United States, 11215
Actively Recruiting
7
Epic Medical Research
DeSoto, Texas, United States, 75115
Actively Recruiting
8
DM Clinical Research
Tomball, Texas, United States, 77375
Actively Recruiting
Research Team
C
Clinical Trial Lead
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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