Меню
Идёт набор NCT05666960

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Фаза I С лечением Ulcerative Colitis Chronic Mild Ulcerative Colitis Chronic Moderate Ulcerative Colitis Chronic Ulcerative Colitis

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: R-3750.
Кому может быть актуально
Состояния в реестре: Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic, Ulcerative Colitis. Базовые параметры: 18 лет — 65 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Обзор

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate ulcerative colitis. Patients will take an oral dosage of probiotic (R-3750) and provide patient-reported and physician scored measures of their colitis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.

Вмешательства

  • Препарат R-3750
    Probiotic

Первичные конечные точки

  • To assess the tolerability of R-3750 [Срок оценки: 6 weeks]
Вторичные конечные точки (1)
  • Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • 18-65 years of age
  • Ability to provide written informed consent
  • Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9
  • On a stable dose of aminosalicylate (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than the study drug
  • For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal contraceptives, intrauterine device (IUD) or hormone releasing system (IUS), vasectomy) and men will refrain from donating sperm during the study and at least 30 days after dosing (per FDA guidelines)
  • For the expansion cohort, a flexible sigmoidoscopy is required, unless an endoscopy was completed within 3 months from enrollment is available
  • Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio)

Критерии исключения

  • Pregnancy, planned pregnancy, breastfeeding women
  • Evidence of severe UC disease (MMDAI score greater than or equal to 10)
  • Evidence of any active or recent infection including chronic infectious disease such as Hepatitis B, C, or HIV
  • Evidence of any active or recent chronic chest infection with bronchiectasis or sinusitis, or covid-19 infection in the past 3 months
  • Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, ozanimod, tofacitinid, upadacitinib, tacrolimus, cyclophosphamide, or cyclosporine or any other therapy that is not an aminosalicylate within the last 3 months
  • Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entry
  • Use of steroidal drugs to treat UC (e.g., prednisone >20 mg/day)
  • Use of probiotics within the last one (1) week and during the trial.
  • Treatment with systemic broad-spectrum antibiotics in the past 2 months
  • Major active systemic autoimmune disease other than UC
  • History of anaphylaxis or allergies to probiotics
  • History of alcohol or drug abuse within the past 2 years
  • History of stroke, or any cerebrovascular disease requiring medication/treatment
  • History of cancer, apart from successfully treated basal cell carcinoma or in situ carcinoma of the cervix >1 year prior to enrollment
  • Significant laboratory abnormalities, including liver transaminases (AST or ALT) > 1.5X the upper limit of normal.
  • Second degree or higher heart block or clinically significant arrythmia
  • Any other clinically significant renal, hepatic, hematological or other disease or laboratory abnormality which, in the opinion of the investigator, would interfere with the conduct, the interpretation of the safety signals or results of the trial, or would place the subject at unacceptable risk
  • Any condition or circumstance that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the quality of study data

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 5 центров
  • Amicis Research Center — Valencia
  • AP Medical Research LLC — Miami
  • Edward Jenner Research Group, LLC — Plantation
  • Adtremed Research Clinic — Tampa
  • Mayo Clinic — Rochester

Идентификаторы

NCT: NCT05666960 · RISE R-3750-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗