This Phase II study is a monocenter, long-term extension study of study GNC-401 and will start after individual completion of Week 48 of the GNC-401 study. At entry, all patients will receive active treatment with temelimab. The patients of the placebo group in study GNC-401 will be re-randomized to temelimab 18 mg/kg, 36 mg/kg or 54 mg/kg (1:1:1), while the patients who received temelimab in study GNC-401 will continue with the same dose in study GNC-402. Following final analysis of the results of the GNC-401 study, the Sponsor may switch all patients to an optimal dose of temelimab based on safety and efficacy demonstrated in the GNC-401 study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
temelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)
temelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)
temelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)
Center for Neurology, Academic Specialist Center
Stockholm, Sweden
safety and tolerability:adverse event
Number of Patients With Treatment-Related Adverse Events
Time frame: 48 weeks
Neuroimaging
Change in Brain parenchymal volume fraction at Week 48 compared to Baseline
Time frame: 48 weeks
Neuroimaging
change in magnetization transfer Saturation (MTSat) in periventricular NAWM at at Week 48 compared to Baseline
Time frame: 48 weeks
Neuroimaging
Change in thalamic volume fraction at Week 48 compared to Baseline
Time frame: 48 weeks
Neuroimaging
Change in magnetization Transfer Saturation (MTSat) in cortex at Week 48 compared to Baseline
Time frame: 48 weeks
Neuroimaging
Change in T1 and T2 lesion volume at Week 48 compared to Baseline
Time frame: 48 weeks
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