NCT04875975终止2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 27
- 主要终点
- Number of Seizure Free Study Participants at the End of the Treatment
研究概览
简要总结
The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, change in cognitive function, use of rescue medication, onset of seizure freedom and to assess safety and tolerability.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participant must be ≥18 to ≤89 years of age
- •Study participant must be seropositive for leucine-rich glioma inactivated 1 (LGI1) antibody
- •Study participant must have ≥2 seizures/week during the Screening Period or have experienced such seizures that stopped following high dose corticosteroids (500 to 1000 milligram (mg) methylprednisolone (MP) equivalent/day):
- •Either faciobrachial dystonic seizures (FBDS) with or without other focal (partial) seizures including focal to bilateral tonic clonic
- •Or focal (partial) seizures including focal to bilateral tonic clonic and fulfil the following new-onset Autoimmune encephalitis (AIE) criteria
- •Study participant has initiated or re-initiated corticosteroids at a dose of 500 to 1000 mg MP equivalent/day within 42 days prior to randomization. Participants re-initiating corticosteroids are eligible only if re-initiation is due to seizure rebound and within the timeframe outlined. If the study participant has initiated a steroid taper, the study participant cannot receive an oral steroid dose lower than 40mg/day when randomized
- •Study participant with onset of disease symptom between 0 to 12 months prior to Screening, per investigator's assessment.
- •Study participant weighs at least 35 kg at Screening
- •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the final dose of study treatment
排除标准
- •Study participant has a known hypersensitivity to any components of the study medication or any other anti-neonatal Fc receptor (FcRn) medications.
- •Study participant has a confirmed prior diagnosis of epilepsy or new onset seizures that are unrelated to LGI1 autoimmune encephalitis (AIE) or has any known or suspected medical cause for the onset of seizures other than possible AIE
- •Study participant has a known active neoplastic disease or history of neoplastic disease within 5 years of study entry
- •Study participant has renal impairment, defined as glomerular filtration rate (GFR) <30mL/min/1.73m2 at the Screening Visit
- •Study participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by investigator, including participants with a serious infection within 6 weeks prior to the first dose of investigational medicinal product (IMP)
- •Study participant has a history of chronic ongoing infections
- •Study participant has current unstable liver or biliary disease, per investigator assessment, defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis
- •Study participant has positive tuberculosis (TB) test at the Screening Visit
- •Study participant has a history of solid organ transplant or hematopoietic stem cell transplant
- •Study participant has undergone a splenectomy
- •Study participant has a current or medical history of primary immune deficiency
- •Study participant has received a live vaccination within 4 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of investigational medicinal product (IMP)
- •Study participant has previously received rozanolixizumab drug product
- •Alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) are >3x upper limit of normal (ULN)
- •Study participant has a total IgG level ≤5.5 g/L at the Screening Visit
- •Study participant has absolute neutrophil count <1500 cells/mm^3 at the Screening Visit
研究组 & 干预措施
Rozanolixizumab
Experimental
Participants will be randomized to receive a predefined dose of rozanolixizumab.
干预措施: Rozanolixizumab (Drug)
Placebo
Placebo Comparator
Participants will be randomized to receive a dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Seizure Free Study Participants at the End of the Treatment
时间窗: From Baseline until the end of the Treatment (Week 25)
Seizure freedom was defined as a minimum of 28 consecutive days of no seizures of any type during the treatment and maintained until the end of the treatment (Week 25).
次要结局
- Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment(From Baseline to Week 5, 13, 21 and 25)
- Percentage of Participants With a Favorable Outcome in the Modified Rankin Scale (mRS) During the Treatment(From Baseline until the end of the Treatment (Week 25))
- Number of Participants Who Required Rescue Medication Due to an Absence or Loss of Clinical Benefit During the Treatment(From Baseline until the end of the Treatment (Week 25))
- Time to First Occurrence of Seizure Freedom During the Treatment(From Baseline until the end of the Treatment (Week 25))
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)(From Baseline until the End of Study (Week 32))
研究者
研究点 (27)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)NCT05063162UCB Biopharma SRL113
已完成
2 期
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia SyndromeFibromyalgiaNCT05643794UCB Biopharma SRL63
已完成
2 期
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating PolyradiculoneuropathyChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)NCT03861481UCB Biopharma S.P.R.L.34
已完成
2 期
MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)Alzheimer's DiseaseNCT00420420Merck Sharp & Dohme LLC144
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy ParticipantsHealthy ParticipantsNCT04736134Bristol-Myers Squibb88