Идёт набор NCT07225504

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Фаза III С лечением Secondary Progressive Multiple Sclerosis (SPMS)

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: Remibrutinib (blinded), Placebo, Remibrutinib (Open label).
Кому может быть актуально: Состояния в реестре: Secondary Progressive Multiple Sclerosis (SPMS). 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, Аргентина, Австралия, Австрия, Бельгия +27
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, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

Обзор

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Подробное описание

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo.

The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.

Вмешательства

Препарат Remibrutinib (blinded)
Remibrutinib (Blinded) active treatment, oral tablet
Препарат Placebo
Matching placebo (binded), oral tablet
Препарат Remibrutinib (Open label)
Remibrutinib (Open Label), oral tablet

Первичные конечные точки

Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS) [Срок оценки: From baseline up to approximately 5 years]

Вторичные конечные точки (8)

Time to 3-month confirmed disability progression (3mCDP) on EDSS [Срок оценки: From baseline up to approximately 5 years]
Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Срок оценки: From baseline up to approximately 5 years]
Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW) [Срок оценки: From baseline up to approximately 5 years]
Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT) [Срок оценки: From baseline up to approximately 5 years]
Annualized rate of new or enlarging T2 lesions [Срок оценки: From baseline up to approximately 5 years]
Annualized rate of brain atrophy [Срок оценки: From baseline up to approximately 5 years]
Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT) [Срок оценки: From baseline up to approximately 5 years]
Number of participants with Adverse events and Serious adverse events (SAE) [Срок оценки: From baseline up to approximately 5 years]

Критерии участия

Критерии включения

Signed informed consent must be obtained prior to any assessment performed.
Male or female participants aged 18-65 (inclusive) at Screening.
Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening
Absence of documented clinical relapses in the 24 months before Screening and randomization.
EDSS score of 3.0 to 6.0 (inclusive) at Screening.
Documented evidence of disability progression in the 12 months before Screening.

Критерии исключения

Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).
History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).
Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.
Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.
Significant bleeding risk or coagulation disorders, at Screening.
Use of exclusionary medication prior to Screening/randomization as listed in the protocol.

Other protocol-defined inclusion/exclusion critria may apply

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: Четверное слепое
Основная цель: Лечение