Clinical Study to Evaluate the Effects of the Complement C5 Inhibitor Ravulizumab on Serum Neurofilament Light Chain (sNfL) and Glial Fibrillary Acidic Protein (sGFAP) Levels in Patients With Aquaporin-4-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD)

ConditionNMOSD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens

About this trial

This is a nationwide observational study looking at how ravulizumab, a complement C5 inhibitor, affects blood biomarkers o sNfL and sGFAP in people with AQP4-antibody positive NMOSD. The study does not change your treatment-only regular blood samples are collected to monitor these markers

Eligibility criteria

Qualifiers

Patient must be 18 years of age or older, at the time of signing the informed consent.

Anti-AQP4 Ab-positive at screening and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria (Wingerchuk, 2015). A historically positive anti-AQP4 Ab test may be acceptable if the test was performed using an acceptable, validated cell-based assay from an accredited laboratory.

At least 1 clinical attack prior to the Prescreening/Screening Periods.

Treatment-naïve patients or patients under specific off-label treatments (rituximab, corticosteroids, azathioprine, mycophenolate mofetil) or the complement C5 inhibitor ravulizumab. Naïve patients who initiate ravulizumab at enrolment, should have been prescribed ravulizumab, but not yet initiated treatment, according to the label and local market reimbursement criteria.

Disqualifiers

History of N. meningitidis infection.

Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer)

History of unexplained infections.

Active systemic bacterial, viral, or fungal infection within 14 days prior to screening.

Trial design

Treatments tested in this trial

  • Blood samples for sNfL and sGFAP levels

Treatment groups

40 Participants
are divided into 2 treatment groups