Идёт набор NCT07186101

LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

Фаза II С лечением 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: LY4268989, Mirikizumab, LY4268989 Placebo.
Кому может быть актуально: Состояния в реестре: Ulcerative Colitis. 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, Австрия, Бразилия, Канада, Китай +12
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, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis

Обзор

The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Вмешательства

Препарат LY4268989
Administered PO
Препарат Mirikizumab
Administered IV then SC
Препарат LY4268989 Placebo
Administered PO

Первичные конечные точки

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [Срок оценки: Week 12]

Вторичные конечные точки (9)

Percentage of Participants Who Achieve Clinical Response with mMS [Срок оценки: Week 12]
Percentage of Participants Who Achieve Endoscopic Improvement [Срок оценки: Week 12]
Percentage of Participants Who Achieve Symptomatic Remission [Срок оценки: Week 12]
Percentage of Participants Who Achieve Clinical Remission with mMS [Срок оценки: Week 24]
Percentage of Participants Who Achieve Clinical Response with mMS [Срок оценки: Week 24]
Percentage of Participants Who Achieve Clinical Remission with mMS [Срок оценки: Week 48]
Percentage of Participants Who Achieve Clinical Response with mMS [Срок оценки: Week 48]
Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA) [Срок оценки: Week 48]
Percentage of Participants Who Achieve Clinical Response with mMS + PGA [Срок оценки: Week 48]

Критерии участия

Критерии включения

Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC
Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.
Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization
Are up-to-date on colorectal cancer surveillance per local society guidelines
Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)

NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)

Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:

a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12/23, or IL-23p19), except for

mirikizumab.
Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib
sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod

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 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 adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed

Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply

Have a current or recent acute, active infection

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 · 40 центров

Mayo Clinic in Arizona - Scottsdale — Scottsdale
Clinnova Research - Anaheim — Anaheim
Om Research LLC — Lancaster
Biopharma Informatic, LLC — Los Angeles
Peak Gastroenterology Associates — Colorado Springs
NeoClinical Research — Hialeah
Encore Borland-Groover Clinical Research — Jacksonville
Clinical Research of Osceola — Kissimmee
… и ещё 32 центра

Бразилия · 14 центров

Chronos Pesquisa Clínica — Brasília
CAEP - Synvia Labs — Campinas
Fundação Universidade de Caxias do Sul (FUCS) — Caxias do Sul
Centro Digestivo de Curitiba — Curitiba
Galileo Medical Research — Juiz de Fora
NewData Clinical Research - Maceió — Maceió
Hospital Ernesto Dornelles — Porto Alegre
Centro Internacional de Pesquisa Clínica (CIPES) — São José dos Campos
… и ещё 6 центров

Китай · 12 центров

Changzhou Second People's Hospital — Changzhou
Chongqing General Hospital — Чунцин
The First Affiliated Hospital Of Fujian Medical University — Фучжоу
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Ханчжоу
First Affiliated Hospital of Kunming Medical University — Куньмин
Jiangsu Province Hospital — Нанкин
The Affiliated Hospital of Qingdao University — Qingdao
Shengjing Hospital of China Medical University — Шэньян
… и ещё 4 центра

Мексика · 12 центров