The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis. The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
Monthly IV
Hospital
Sofia, Bulgaria
Hospital
Zagreb, Croatia
Hospital
Jihlava, Czechia
Hospital
Tallinn, Estonia
Long term safety of GNbAC1
The main parameters evaluated to assess the long term safety will be: AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale
Time frame: 96 Weeks
Long term efficacy of GNbAC1 in terms of MRI outcomes
Time frame: 96 Weeks
Long term efficacy of GNbAC1 in terms of relapse rate
Time frame: 96 Weeks
Long term efficacy of GNbAC1 in terms of disability
Time frame: 96 Weeks
Long term efficacy of GNbAC1 in terms of disease progression
Time frame: 96 Weeks
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...and 2 more locations