Safety Study of GNbAC1 in Multiple Sclerosis Patients

Inclusion criteria

• Male or female patients (if female, neither pregnant nor breast-feeding, should be post-menopausal or surgically sterile, or should use two highly effective method of contraception such as oral contraception plus mechanical barrier); Male subjects with partners of childbearing potential have to use adequate contraception during the study. Contraception methods should be followed during the study and up to 3 months after the last study drug administration. Female subjects who are women of childbearing potential (WOCBP) will have to be tested negative with a pregnancy test (serum or urine) at screening and Day 1 and before each repeated administrations of GNbAC1.
• Between 18 and 65 years of age;
• Patients with Primary Progressive MS (PPMS) according to the Revised McDonald criteria 2010 or patients with Secondary Progressive MS (SPMS) or patients with Relapsing-Remitting MS(RRMS)according to the Revised McDonald criteria 2010 who cannot be treated with available treatments for MS due to intolerance, non response or refusal of treatment;
• Score ≤ 6.5 on the Expanded Disability Status Scale (EDSS);
• Body weight between 40 and 100kg.

Exclusion criteria

• Positive serology for viral hepatitis and HIV;
• Disease other than MS that could better explain his/her signs and symptoms;
• Previously treated with cladribine, lymphoid irradiation or depleting antibodies;
• Usage in the last 3 months of interferon beta or glatiramer acetate;
• Any usage in the last 6 months of mitoxantrone, cytotoxic immunosuppressive therapy, natalizumab, fingolimod or immunoglobulin;
• Usage within 30 days prior to baseline of oral or systemic corticosteroids or ACTH;
• Inadequate liver function;
• Severe renal impairment;
• Severe psychiatric disorder;
• Known inability to undergo an MRI scan;
• Having participated in another clinical study within 6 months prior to study baseline except for patients who have participated or who are currently participating in an interventional study without any study drug intake.
• Pregnancy or breastfeeding
• Female subjects considering becoming pregnant during the study