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A Study of Dotinurad Versus Allopurinol in Participants With Gout

RecruitingPhase 3Ages 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 study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.

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. 3. Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records). 4. Participant must be on a stable background allopurinol dose of โ‰ฅ300 mg/day (200 mg/day for those with moderate renal impairment as documented in the participant's medical history) up to 600 mg/day for at least 3 months prior to Screening and remain on their dosing regimen until Day 1. 5. sUA level โ‰ฅ6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit). 6. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding. 7. 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 study 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. Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs. 4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse. 5. Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening. 6. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.
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What it tests

  • Allopurinol
  • Dotinurad
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Where

115 sites
University of Alabama at Birmingham
Birmingham, United States
Alabama Clinical Therapeutics
Birmingham, United States
G&L Research
Foley, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, United States
Del Sol Research Management - Tucson East
Tucson, United States
Medvin Clinical Research - Covina
Covina, United States

โ€ฆand 107 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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