A study to test the efficacy, safety, and pharmacokinetics of rozanolixizumab in adult study participants with Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Phase 1

Conditions: eucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
MedDRA version: 20.0Level: PTClassification code 10072378Term: Encephalitis autoimmuneSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2019-004778-25-PT

Lead Sponsor: CB Biopharma SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 68

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 methyl prednisolone (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
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

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