Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis MedDRA version: 20.0 Level: PT Classification code 10072378 Term: Encephalitis autoimmune System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Rozanolixizumab
Product Code: UCB7665
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Rozanolixizumab
CAS Number: 1584645-37-3
Current Sponsor code: UCB7665
Other descrip
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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 renal impairment, defined as glomerular filtration rate (GFR) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 -To assess the efficacy of rozanolixizumab on study participants' overall disability -Assess the efficacy of rozanolixizumab as measured by use of rescue medication -Assess the efficacy of rozanolixizumab as measured by the onset of seizure freedom -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
| Measure | Time frame |
|---|---|
| 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 2. Proportion of participants with a favorable outcome in the Modified Rankin Scale (mRS) during the Treatment Period 3. Proportion of participants who required rescue medication due to an absence or loss of clinical benefit during the Treatment Period 4. Time to first occurrence of seizure freedom during the Treatment Period 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) 5: From Baseline until the End of Study Visit (Week 32) | — |
Countries
Australia, Belgium, Denmark, France, Germany, Italy, Korea, Republic of, Netherlands, Portugal, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed