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AIE001

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

Brief summary

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.

Medical Condition

Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Min. Age

18
Years

Max. Age

89
Years

Who Can Join?

All

Status

Recruiting
Inclusion criteria
-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 intravenous methylprednisolone (IVMP) initiation: • 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 is deemed appropriate for initiation of IVMP based on clinical symptoms and history or has initiated IVMP treatment at a dose of 500 to 1000 mg/day within 14 days prior to randomization. If the study participant has initiated a steroid taper, the study participant cannot be receiving an oral steroid dose lower than 60 mg/day when randomized. -Study participant with onset of disease between 0 to 12 months prior to Screening -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
Exclusion criteria
-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 12-lead electrocardiogram (ECG) with findings considered clinically significant by the investigator -Study participant has renal impairment, defined as glomerular filtration rate (GFR) <30mL/min/1.73m2 at the Screening Visit. -Study participant has a clinically relevant active infection or has had a serious infection within 6 weeks prior to the first dose of 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 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 8 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 Medication Description

Study Medication:

rozanolixizumab

Other Descriptive Name:

rozanolixizumab

Placebo

Yes

Comparator:

No

Study Dates

September 2021

Actual Start Date of Enrollment

November 2023

Planned Study Completion Date

General Information

Study ID:
AIE001
EudraCT Number:
2019-004778-25
CT.gov Number:
NCT04875975
Phase:
Phase 2

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