A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 100
- 主要终点
- Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC)
研究概览
简要总结
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are aged >=12 years at the time of signing Informed Consent Form
- •Confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening
- •Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
- •High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening
- •Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
- •For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
排除标准
- •Presence of aquaporin-4-antibodies immunoglobin G (AQP4-IgG) in the serum
- •History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
- •Any concomitant disease other than MOGAD that may require treatment with ISTs or oral corticosteroids (OCS) or intravenous (IV) corticosteroids at doses > 20 milligrams (mg) prednisone equivalent per day for >21 days during the study
- •Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
- •Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
- •Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
- •Participants with positive screening tests for hepatitis B and C
- •Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
- •History of severe allergic reaction to a biologic agent
研究组 & 干预措施
Placebo
In the DB treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses Q4W thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.
干预措施: Placebo (Other)
Satralizumab
In the DB treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open-label treatment with satralizumab. Additional adolescent participants will be directly enrolled in the OLE period to receive satralizumab.
干预措施: Satralizumab (Drug)
结局指标
主要结局
Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC)
时间窗: Up to approximately 44 months
次要结局
- Proportion of Participants Receiving Rescue Therapy(Up to approximately 44 months)
- Annualized Rate of Inpatient Hospitalizations(Up to approximately 44 months)
- Annualized Rate of Adjudicated MOGAD Relapses(Up to approximately 44 months)
- Annualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis(Up to approximately 44 months)