FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University General Hospital
About this trial
NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord and optic nerves. The objectives of this study are to assess the efficacy and safety of FcRn antagonists (efgartigmod) for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. The potential of efgartigimod, an IgG1 Fc fragment that competes with IgG for FcRn binding, thereby lowering IgG levels, warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks. This study aims to evaluate the therapeutic potential of efgartigmod in acute NMOSD attack.
Eligibility criteria
Qualifiers
Male or female, ages 18 to 75.
Meet the 2015 International Panel of Experts (IPND) diagnostic criteria for neuromyelitis optica spectrum disorders.
Acute EDSS nadir of 2.5-7.5, and a change of at least 0.5 points from baseline due to an acute relapse event.
Confirmation of serum AQP4-IgG antibody positivity using the CBA assay.
Disqualifiers
Other core clinical symptoms besides optic neuritis and myelitis.
Severe neuromyelitis optica spectrum disorder attack, which in the judgment of the investigator is not appropriate for this study. Severe is defined as requiring assisted ventilation or likely to require assisted ventilation during the study based on the judgment of the investigator.
Subjects with total IgG levels ≤ 6 g/L at screening.
Subjects with a B-cell count ≤ 5% of the lower limit of normal at screening.
Trial design
Treatments tested in this trial
- Efgartigimod Alfa Injection
- High-dose intravenous methylprednisolone
Treatment groups
63 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Tianjin Medical University General Hospital
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Source ClinicalTrials.gov