A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rozanolixizumab
The study is composed of Extended Observation Period(s) and Symptom-driven Cycle(s). Based on their clinical need for treatment, study participants will be able to start the study with either an Extended Observation Period or a Symptom-driven Cycle.
A Symptom-driven Cycle will be initiated based on disease worsening and participants will receive rozanolixizumab based on investigator's medical judgement.
干预措施: Rozanolixizumab (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years
Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.
Incidence of treatment-emergent serious adverse events (TESAEs)
时间窗: Up to 2 years
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Incidence of TEAEs leading to permanent withdrawal of study treatment
时间窗: Up to 2 years
Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. This measure considers any TEAE leading to permanent withdrawal from study.
次要结局
- Study participant who generalizes to Myasthenia Gravis Foundation of America (MGFA) class ≥2 over time(Up to 2 years)
- Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome part)(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(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(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(At Day 43 (of the first 3 Symptom-driven Cycles))
- Change from Baseline in MGII total and generalized score over time(Up to 2 years)
- Change from Baseline in MG-ADL total score over time(Up to 2 years)