A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

Официальное название

A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

Обзор

The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.

Вмешательства

• Препарат Rozanolixizumab
  Rozanolixizumab will be administered by subcutaneous infusion.

Первичные конечные точки

• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 2 years]
• Incidence of treatment-emergent serious adverse events (TESAEs) [Срок оценки: Up to 2 years]
• Incidence of TEAEs leading to permanent withdrawal of study treatment [Срок оценки: Up to 2 years]

Вторичные конечные точки (7)

• Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome part) [Срок оценки: At Day 43 (of the first 3 Symptom-driven Cycles)]
• Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular score [Срок оценки: At Day 43 (of the first 3 Symptom-driven Cycles)]
• Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score [Срок оценки: At Day 43 (of the first 3 Symptom-driven Cycles)]
• Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score [Срок оценки: At Day 43 (of the first 3 Symptom-driven Cycles)]
• Study participant who generalizes to Myasthenia Gravis Foundation of America (MGFA) class ≥2 over time [Срок оценки: Up to 2 years]
• Change from Baseline in MGII total and generalized score over time [Срок оценки: Up to 2 years]
• Change from Baseline in MG-ADL total score over time [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)
• Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG0038
• Participant for whom the investigator considers a favorable benefit/risk for participation
• Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator
• Male or female
• A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies:

• Not a woman of childbearing potential (WOCBP)
• OR
• A WOCBP who agrees to follow the contraceptive guidance for the entire study period
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol

Критерии исключения

• Participant meets any of the withdrawal criteria defined in MG0038
• Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry.
• Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab
• Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies
• Participant has planned use of prohibited medications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07465289 · MG0039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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