Идёт набор NCT07503873
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
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: Ublituximab, Ublituximab, Prefilled pen.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis. 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
- Bosnia and Herzegovina, Грузия, North Macedonia, Польша, Сербия +1
- 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, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis
Обзор
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
Вмешательства
- Препарат Ublituximab
Administered as an SC injection by a syringe. - Препарат Ublituximab
Administered as an SC injection by prefilled pen. - Устройство Prefilled pen
Ublituximab will be administered as an SC injection by prefilled pen.
Первичные конечные точки
- Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab [Срок оценки: Up to Week 12]
Вторичные конечные точки (5)
- Part 1: Plasma Concentrations of Ublituximab [Срок оценки: Up to Week 24]
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to Week 120]
- Part 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC) [Срок оценки: Up to Week 96]
- Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab [Срок оценки: pre-dose and at multiple timepoints post-dose up to Week 120]
- Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab [Срок оценки: pre-dose and at multiple timepoints post-dose up to Week 120]
Критерии участия
Критерии включения
- Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).
- Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.
- Neurologically stable for more than (>) 30 days prior to screening and Day 1.
- Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab.
Критерии исключения
- Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS).
- Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
- Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
- Participants who received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
- Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.
- Females who are pregnant or nursing.
Note: Other protocol-specified Inclusion/Exclusion criteria 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
- Открытое
- Основная цель
- Лечение
Центры проведения
Украина · 20 центров
- TG Therapeutics Investigational Trial Site — Chernihiv
- TG Therapeutics Investigational Trial Site — Chernihiv
- TG Therapeutics Investigational Trial Site — Ivano-Frankivsk
- TG Therapeutics Investigational Trial Site — Ivano-Frankivsk
- TG Therapeutics Investigational Trial Site — Ivano-Frankivsk
- TG Therapeutics Investigational Trial Site — Kyiv
- TG Therapeutics Investigational Trial Site — Kyiv
- TG Therapeutics Investigational Trial Site — Kyiv
- … и ещё 12 центров
Польша · 7 центров
- TG Therapeutics Investigational Trial Site — Bydgoszcz
- TG Therapeutics Investigational Trial Site — Katowice
- TG Therapeutics Investigational Trial Site — Katowice
- TG Therapeutics Investigational Trial Site — Kielce
- TG Therapeutics Investigational Trial Site — Lodz
- TG Therapeutics Investigational Trial Site — Poznan
- TG Therapeutics Investigational Trial Site — Warsaw
Bosnia and Herzegovina · 4 центра
- TG Therapeutics Investigational Trial Site — Bihać
- TG Therapeutics Investigational Trial Site — Sarajevo
- TG Therapeutics Investigational Trial Site — Tuzla
- TG Therapeutics Investigational Trial Site — Zenica
Грузия · 4 центра
- TG Therapeutics Investigational Trial Site — Tbilisi
- TG Therapeutics Investigational Trial Site — Tbilisi
- TG Therapeutics Investigational Trial Site — Tbilisi
- TG Therapeutics Investigational Trial Site — Tbilisi
North Macedonia · 2 центра
- TG Therapeutics Investigational Trial Site — Shtip
- TG Therapeutics Investigational Trial Site — Skopje
Сербия · 2 центра
- TG Therapeutics Investigational Trial Site — Belgrade
- TG Therapeutics Investigational Trial Site — Kragujevac
Идентификаторы
NCT: NCT07503873 · TG1101-RMS-SC201 · 2025-523757-33-00