Идёт набор NCT07415044

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Фаза II С лечением Ulcerative Colitis (UC) Ulcerative Colitis, Active Moderate Ulcerative Colitis, Active Severe

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: LY4268989, Placebo.
Кому может быть актуально: Состояния в реестре: Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe. Базовые параметры: 18 лет — 80 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, Аргентина, Бразилия, Канада, Китай +23
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 Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

Обзор

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.

Вмешательства

Препарат LY4268989
Administered orally
Препарат Placebo
Administered orally

Первичные конечные точки

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [Срок оценки: Week 10]
Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Срок оценки: Week 52]

Вторичные конечные точки (6)

Percentage of Participants Who Achieve Clinical Response with mMS [Срок оценки: Week 10]
Percentage of Participants Who Achieve Clinical Response with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Срок оценки: Week 10 Up to Week 52]
Percentage of Participants Who Achieve Symptomatic Response [Срок оценки: Baseline Up to Week 8]
Percentage of Participants Who Achieve Symptomatic Response Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Срок оценки: Week 10 Up to Week 52]
Pharmacokinetics (PK): Plasma Concentrations of LY4268989 [Срок оценки: Baseline Up to Approximately Week 52]
Percentage of Participants Who Achieve Clinical Remission Among Participants Who Achieved Clinical Remission with LY4268989 at Week 10 [Срок оценки: Week 52]

Критерии участия

Критерии включения

Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
Have evidence of UC extending proximal to the rectum
Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded
Must meet contraception requirements

Критерии исключения

Have a current diagnosis of

Crohn's disease
Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or
primary sclerosing cholangitis
Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
Have had or will need bowel resection or intestinal or intra-abdominal surgery
Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies
Have a diagnosis or history of malignant disease within 5 years prior to randomization

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 · 52 центра

Valleywise Health Medical Center — Phoenix
One of a Kind Clinical Research Center — Scottsdale
Clinnova Research — Anaheim
GMC Clinical Research — Folsom
Om Research LLC — Temple City
Om Research LLC — Victorville
Peak Gastroenterology Associates — Colorado Springs
Advanced Research Institute - Denver — Denver
… и ещё 44 центра

Китай · 22 центра

Binzhou Medical University Hospital — Binzhou
Changzhou Second People's Hospital — Changzhou
Sichuan Provincial People's Hospital — Чэнду
Chongqing General Hospital — Чунцин
The First People's Hospital of Foshan — Foshan
The Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
… и ещё 16 центров

Индия · 16 центров