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Идёт набор NCT07535034

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

Фаза II С лечением Gout

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dotinurad, Placebo.
Кому может быть актуально
Состояния в реестре: Gout. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат Dotinurad
    Over-encapsulated tablets containing active drug substance administered orally.
  • Другое Placebo
    Capsules containing microcrystalline cellulose administered orally.

Первичные конечные точки

  • Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 [Срок оценки: Week 24]
Вторичные конечные точки (7)
  • Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 [Срок оценки: 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 [Срок оценки: Up to Week 40]
  • Mean Change From Baseline in sUA at Week 24 [Срок оценки: Baseline and Week 24]
  • Absolute Change from Baseline in sUA Levels at Each Visit [Срок оценки: Baseline to Week 40]
  • Percent Change from Baseline in sUA Levels at Each Visit [Срок оценки: Baseline to Week 40]
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Treatment Periods 1 and 2 [Срок оценки: Screening to Week 36]
  • Number of Participants With TEAEs and SAEs Throughout the Study [Срок оценки: Screening to Week 40]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 29 центров
  • 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
  • … и ещё 21 центр

Идентификаторы

NCT: NCT07535034 · FYU-981-CRYS-201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗