A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis...
Neuromyelitis Optica Spectrum DisordersThe purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders...
Neuromyelitis Optica Spectrum DisordersThis study is a phase I clinical study of the safety, tolerability, and pharmacokinetics of BAT4406F injection in patients with neuromyelitis optica spectrum disorders.
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
Neuromyelitis Optica Spectrum DisorderThe primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention
Neuromyelitis Optica Spectrum DisorderNMOSDObjective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab (RTX) (or its biosimilar)
A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders...
Optic Neuromyelitis Spectrum DiseaseThis is a phase II/III multicenter, randomized, double-blind, placebo-controlled study, to investigate the efficacy and safety of BAT4406F injection in patients with neuromyelitis optica lineage disease (NMOSD) who are positive for aquaporin 4 antibody (AQP4-IgG) .
Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis...
Neuromyelitis OpticaNeuromyelitis Optica Spectrum Disorder1 moreThe objectives of this time-to-event study were to assess the efficacy and safety of Daratumumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive. NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord, optic nerves, and area postrema. It is usually mediated by the pathogenic AQP4-IgG. Antibody-secreting cells (ASCs) have been recognized as essential sources of AQP4-IgG. CD38 is a glycoprotein that is highly expressed on ASCs. Daratumumab, a CD38-directed monoclonal antibody, has been shown to decrease the levels of autoantibodies in lupus, myasthenia gravis, or autoimmune encephalitis. This randomized controlled study aims to evaluate the therapeutic potential of daratumumab in NMOSD.
Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders
NMO Spectrum DisorderNeuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Belimumab (Benlysta ®) is a human immunoglobulin G1λ monoclonal antibody that inhibits B-cell survival and differentiation by neutralizing soluble B lymphocyte stimulator. Belimumab may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.
Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders
NMO Spectrum DisorderNeuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor that blocks the upregulated JAK-STAT pathway in patients with neuroimmune disorders, which is important in bone marrow regulation of B cell proliferation and differentiation. Baricitinib may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Neuromyelitis OpticaNMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.
In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells...
Neuromyelitis OpticaThis 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.