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

NCT04629274 | Completed

• 1 other identifier: IMCY-NMO-000
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients. A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - i.e. treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease, Neuromyelitis Optica Spectrum Disorders (NMOSD) in this study. The main goal of the study will be to support the selection of Imotopes® (i.e. synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif), and (i) capable of binding with class II HLA antigens of each patient and (ii) causing ex vivo the appearance of epitope -specific cytolytic CD4+ T cells.

Conditions

Neuromyelitis Optica

Outcome Measures

Primary Outcomes (2)

• Measure in vitro binding of Imotopes®

  Characterize, in vitro, the binding of different Imotopes® to class II HLA antigens on PBMC isolated from patients with NMO

  Through study completion, an average of 1 year

• Measure Cytolytic response against Antigen-Presenting Cells (APC)

  Measure the ability of Imotopes® 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 APC presenting the same epitopes)

  Through study completion, an average of 1 year

Study Arms (1)

Test of Imotopes® candidates on blood cells of patients with stabilized NMO

EXPERIMENTAL

To test in vitro the binding of different Imotopes® to class II HLA antigens on 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).

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

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.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

Test of Imotopes® candidates on blood cells of patients with stabilized NMO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imcyse SA: lead

Study Sites (2)

Hôpital Pierre Wertheimer

Bron, 69500, France

Location

Hôpital de Hautepierre

Strasbourg, 67200, France

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jerome De Seze, MD

  Hôpital de Hautepierre, Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 16, 2020
• Study Start: June 15, 2020
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)