Исследование по оценке эффективности и безопасности розаноликсизумаба у взрослых участников с заболеванием, ассоциированным с антителами к миелиновым олигодендроцитам (MOG) (MOG-AD) (cosMOG)
Рандомизированное, двойное слепое, плацебо-контролируемое, многоцентровое, опорное исследование фазы 3 с открытым периодом продления для оценки эффективности и безопасности розаноликсизумаба у взрослых участников с миелиновым олигодендроцитным гликопротеином (MOG) и заболеванием, связанным с антителами (MOG- ОБЪЯВЛЕНИЕ)
The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOGAD).
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Melbourne, Австралия
- Mog001 30022
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Ghent, Бельгия
- Mog001 40185
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Porto Alegre, Бразилия
- Mog001 60033
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Göttingen, Германия
- Mog001 40140
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Münster, Германия
- Mog001 40177
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Athens, Греция
- Mog001 40850
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Barcelona, Испания
- Mog001 40267
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Madrid, Испания
- Mog001 40161
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Murcia, Испания
- Mog001 40350
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Málaga, Испания
- Mog001 40341
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Seville, Испания
- Mog001 40049
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Pavia, Италия
- Mog001 40146
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Roma, Италия
- Mog001 40629
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Verona, Италия
- Mog001 40646
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Culiacán, Мексика
- Mog001 50486
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Mexico City, Мексика
- Mog001 50485
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Bydgoszcz, Польша
- Mog001 40840
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Coimbra, Португалия
- Mog001 40485
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Porto, Португалия
- Mog001 40669
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Liverpool, Соединенное Королевство
- Mog001 40661
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Oxford, Соединенное Королевство
- Mog001 40163
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Arizona
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Scottsdale, Arizona, Соединенные Штаты, 85259-5452
- Mog001 50297
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California
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Palo Alto, California, Соединенные Штаты, 94304
- Mog001 50450
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Colorado
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Aurora, Colorado, Соединенные Штаты, 80045
- Mog001 50101
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District of Columbia
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Washington D.C., District of Columbia, Соединенные Штаты, 20057
- Mog001 50553
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Florida
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Tampa, Florida, Соединенные Штаты, 33612
- Mog001 50308
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Illinois
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Peoria, Illinois, Соединенные Штаты, 61637
- Mog001 50472
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21287
- Mog001 50552
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02114-3117
- Mog001 50243
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Minnesota
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Rochester, Minnesota, Соединенные Штаты, 55905
- Mog001 50104
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Texas
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San Antonio, Texas, Соединенные Штаты, 78229
- Mog001 50568
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84112
- Mog001 50473
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Istanbul, Турция (Туркие)
- Mog001 40550
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Izmir, Турция (Туркие)
- Mog001 40726
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Samsun, Турция (Туркие)
- Mog001 40648
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Sancaktepe, Турция (Туркие)
- Mog001 40725
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Kyiv, Украина
- Mog001 20319
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Ternopil, Украина
- Mog001 20228
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Strasbourg, Франция
- Mog001 40170
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Hradec Králové, Чехия
- Mog001 40195
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Teplice, Чехия
- Mog001 40721
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Basel, Швейцария
- Mog001 40723
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Bern, Швейцария
- Mog001 40337
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Zurich, Швейцария
- Mog001 40630
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Huddinge, Швеция
- Mog001 40663
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Goyang-si, Южная Корея
- Mog001 20226
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Chiba, Япония
- Mog001 20068
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Isehara, Япония
- Mog001 20307
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Kitakyushu-shi, Япония
- Mog001 20049
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Kodaira, Япония
- Mog001 20143
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Koriyama-shi, Япония
- Mog001 20223
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Sendai, Япония
- Mog001 20224
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Sendai, Япония
- Mog001 20227
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Shinjuku-ku, Япония
- Mog001 20070
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Suita-shi, Япония
- Mog001 20032
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
- Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD
- Participant has history of relapsing MOGAD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization
- Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
Exclusion Criteria:
- Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
- Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP)
- Participant has a current or medical history of primary immunodeficiency
- Participant tests positive for aquaporin-4 antibodies at Screening
- Participant has a serum total IgG level ≤ 5.5g/L
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Rozanolixizumab Arm
Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints. |
Participants will receive pre-specified doses of rozanolixizumab.
Другие имена:
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Плацебо Компаратор: Placebo Arm
Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding. |
Participants will receive placebo.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period
Временное ограничение: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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The TTFR (days) will be defined as the interval between the date of randomization and the first date of the objective relapse. During the Double Blind (DB) Treatment Period (Part A); EDB/EWD = End of Double-Blind/Early Withdrawal Visit |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period
Временное ограничение: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Open-Label Extension (OLE) Treatment Period (Part B); EOS/EWD = End of Study/Early Withdrawal Visit. |
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period
Временное ограничение: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported. |
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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For Part A: Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit
Временное ограничение: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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Visual acuity is a measurement of the capacity for visual discrimination of fine details. Visual acuity tests are used to determine the smallest characters that can be read on a standardized chart. The Landolt C Broken Ring Chart uses standardized incomplete rings or "C", which are positioned in any direction in the chart (up, down, left, right, and 45 degree positions in between). The participant has to be able to indicate where the break of the "C" is located, by describing the position or by giving gesture. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)
Временное ограничение: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
|
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments with half steps from 1.0 to 9.5. The higher the value the higher is the level of impairment and disability. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Number of MOGAD related inpatient hospitalizations during the DB Treatment Period
Временное ограничение: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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The total number of MOGAD related hospitalizations from Baseline through EDB/EWD Visit. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period
Временное ограничение: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
|
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period
Временное ограничение: Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An ARR will be calculated for each participant prior to randomization into the Double-Blind Treatment Period (based on available historical data), and 2 ARRs after randomization to study treatment: first for relapses occurring during the Double-Blind Treatment Period and the second for relapses occurring during the OLE Treatment Period. The relapse episodes for each participant will be recorded throughout the entire study. |
Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: UCB Cares, 001 844 599 2273
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MOG001
- 2021-000352-19 (Номер EudraCT)
- 2023-509237-39 (Идентификатор реестра: EU Clinical Trials)
- U1111-1301-0122 (Другой идентификатор: Universal Trial Number (UTN))
- 2023 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Сроки обмена IPD
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Критерии совместного доступа к IPD
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .