Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
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, Placebo, Placebo, Fingolimod.
- Кому может быть актуально
- Состояния в реестре: Relapsing Multiple Sclerosis. Базовые параметры: 10 лет — 17 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
- Польша
- 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
Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Обзор
The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).
Вмешательства
- Препарат Ublituximab
Administered as an intravenous (IV) infusion. - Препарат Placebo
Oral capsule. - Препарат Placebo
IV infusion. - Препарат Fingolimod
Oral capsule.
Первичные конечные точки
- Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab [Срок оценки: Predose and multiple timepoints up to Week 24]
- Part A: Maximum Observed Concentration (Cmax) of Ublituximab [Срок оценки: Day 1 and Day 15]
- Part A: Participant B Cell Counts [Срок оценки: Up to Week 24]
- Part B: Annualized Relapse Rate (ARR) [Срок оценки: Up to 96 weeks]
- Part C: Annualized Relapse Rate (ARR) [Срок оценки: Up to 168 weeks]
Вторичные конечные точки (12)
- Part A, B and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks]
- Part A, B and C: Number of Participants With Change in Columbia-Suicide Severity Rating Scale (C-SSRS ) [Срок оценки: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks]
- Part A: Serum Concentrations of Ublituximab [Срок оценки: Up to Week 24]
- Part A and B: Percentage of Participants with Treatment-emergent Anti-drug Antibodies (ADAs) to Ublituximab [Срок оценки: Part A: Up to Week 24; Part B: Up to 96 weeks]
- Part A and B: Number of Gadolinium Enhancing (Gd-enhancing) T1 Lesions per Magnetic Resonance Imaging (MRI) Scan [Срок оценки: Part A: Up to Week 24; Part B: Up to 96 weeks]
- Part A and B: Number of New and/or enlarging T2 Hyperintense Lesions (NELs) per MRI Scan [Срок оценки: Part A: Up to Week 24; Part B: Up to 96 weeks]
- Past A: Annualized Relapse Rate [Срок оценки: Up to Week 24]
- Part A and C: Change From Baseline in Expanded Disability Status Scale (EDSS) Score [Срок оценки: Part A: Baseline, up to Week 24; Part C: Baseline, up to 168 weeks]
- Part B: Pharmacokinetics (PK) Serum Concentration of Ublituximab [Срок оценки: Up to Week 96]
- Part B: Percentage of Participants with CD19+ B cell counts ≤10 cells/uL [Срок оценки: Up to 96 weeks]
- Part B: Annualized Relapse Rate ARR [Срок оценки: Up to Week 96]
- Part C: Time to Confirmed Disability Progression (CDP) [Срок оценки: Up to Week 24]
Критерии участия
Inclusion Criteria for Part A and Part B:
- Diagnosis of RMS.
- EDSS at screening: 0-5.5, inclusive.
- Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).
Inclusion Criteria for Part C:
1\. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.
Exclusion Criteria for Part A and B:
- Known presence or suspicion of other neurologic disorders that may mimic MS.
- Prior treatments:
- Systemic corticosteroids (>0.1 milligrams/kilogram/day \[mg/kg/day\], or >5 milligrams/day \[mg/day\] of prednisone equivalent) or adrenocorticotropic hormone (ACTH) within 30 days prior to the screening MRI scan (note: Topical, ophthalmic, or inhaled corticosteroids are permitted).
- High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
- Treatment with anti-CD20 or other B cell directed treatment at any time.
- Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.
Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):
- Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
- The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.
Exclusion Criteria for Part C:
1\. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Польша · 2 центра
- TG Therapeutics Investigational Trial Site — Gdansk
- TG Therapeutics Investigational Trial Site — Poznan
Идентификаторы
NCT: NCT07220252 · TG1101-RMS-PED304 · 2025-522257-19-00