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A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants

RecruitingPhase 2Ages 18 Years - 75 YearsAllCrystalys Therapeutics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Dotinurad
  • Placebo
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Where

41 sites
The Kirklin Clinic of UAB Hospital
Birmingham, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, United States
AARA Clinical Research-SE Tucson
Tucson, United States
Amicis Research Center
Granada Hills, United States
Cohen Medical Center
Thousand Oaks, United States
Solace Clinical Research
Tustin, United States
Denver Arthritis Clinic - Lowry
Denver, United States
Omega Research Group
DeBary, United States

โ€ฆand 33 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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