A study to test the efficacy, safety, and pharmacokinetics of rozanolixizumab in adult study participants with Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
- Conditions
- eucine-Rich Glioma Inactivated 1 Autoimmune EncephalitisMedDRA version: 20.0Level: PTClassification code 10072378Term: Encephalitis autoimmuneSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-004778-25-DE
- Lead Sponsor
- CB Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 68
-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 newonset 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the efficacy of rozanolixizumab as measured by seizure freedom;Secondary Objective: -Assess the efficacy of rozanolixizumab as measured by a change in cognitive function<br>-To assess the efficacy of rozanolixizumab on study participants' overall<br>disability<br>-Assess the efficacy of rozanolixizumab as measured by use of rescue medication<br>-Assess the efficacy of rozanolixizumab as measured by the onset of seizure freedom<br>-Assess the safety and tolerability of rozanolixizumab ;Primary end point(s): Proportion of seizure free study participants at the end of the Treatment Period;Timepoint(s) of evaluation of this end point: From Baseline until the end of Treatment Period (Week 25)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score at the end of the Treatment Period<br>2. Proportion of participants with a favorable outcome in the Modified<br>Rankin Scale (mRS) during the Treatment Period<br>3. Proportion of participants who required rescue medication due to an absence or loss of clinical benefit during the Treatment Period<br>4. Time to first occurrence of seizure freedom during the Treatment Period<br>5. Incidence of Treatment-Emergent Adverse Events (TEAEs);Timepoint(s) of evaluation of this end point: 1-4: From Baseline until the end of the Treatment Period (Week 25)<br>5: From Baseline until the End of Study Visit (Week 32)