In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized NMO

This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients.

The objective is to test in vitro the binding of different Imotopes® to class II HLA antigens on peripheral blood mononuclear cell (PBMC) isolated from patients presenting a diagnosed and stabilized neuromyelitis optica spectrum disorders, as well as their ability to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and antigen presenting cells (APC) presenting the same epitopes).

The patients will be asked to provide at least 2 peripheral blood samples of approximately 100 milliliters each time, with a minimum of 14 days interval between these 2 samples. These blood samples will be taken by a member of the healthcare staff qualified to perform this type of procedure. If the results obtained with the 2 initial samples would be of interest to the Sponsor, the patient will be asked to come back for additional samplings with a maximum of 6 additional blood draws. The total volume of blood that will be taken over a 6 months period cannot exceed 500 milliliters with a maximum of 200 milliliters over a 30-day period for patients with a weight of min 50kg. The study has no other constraint.

The list of analysis planned to be performed on blood samples are presented below:

• Identification of the class II HLA antigens of each patient
• Study of the binding to HLA antigens of synthetic peptides
• Identification of peptides which, after binding to the HLA antigens, might induce a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and APC presenting the same epitopes)
• Non selective genomic analysis (SNPs) in the scope of the single cell transcriptomic analysis technics

Inclusion criteria

• Men or women, 18 to 65 years of age
• Patients with a confirmed diagnosis of Neuromyelitis Optica spectrum disorders according to IPND criteria (2015) and presenting a stabilized disease (no relapse) for at least 6 months.
• Patient positive for antibodies to human aquaporin 4
• Patients having granted their written informed consent to take part in this study

Exclusion criteria

• Ongoing pregnancy
• Ongoing treatment with immunosuppressive agents other than those listed below under section "authorized background therapy"
• Any investigational product in the last 3 months or less than 5 times the estimated half-life of the investigational product whichever is the longer