A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

Exclusion Criteria

• •Significant medical diseases or conditions, including poorly controlled hypertension, cardiovascular disease, inflammatory disorders, immunodeficiency, autoimmune disease, renal failure, liver dysfunction, cancer (except treated basal skin cell carcinoma), or active infection.
• •Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
• •History or presence of drug or alcohol abuse.
• •Smoking more than 5 cigarettes or equivalent per day.
• •If female, pregnancy, lactating, or breast-feeding.
• •Patients with relapsing-remitting MS.
• •Lymphocyte counts below the lower limit of normal.
• •Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months.
• •Treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) in the last 12 months, or determined by the treating physician to have residual immune suppression from these treatments.
• •Treatment with glatiramer acetate or interferon beta in the past 4 weeks.
• •Treatment with fingolimod within the past 2 months.
• •Treatment with dimethyl fumarate in past 4 weeks.
• •Treatment with teriflunomide within the past 12 months unless patient has completed an accelerated clearance with cholestyramine.
• •Previous treatment with alemtuzumab.
• •Live, attenuated vaccine within 3 months prior to the randomization visit, such as varicella-zoster, oral polio, and rubella vaccines.
• •Clinically significant abnormality in thyroid function.
• •Inability to undergo magnetic resonance imaging with gadolinium administration.
• •Hypersensitivity or contraindication to acyclovir.
• •Known bleeding disorder.
• •Significant autoimmune disease.
• •Active infection or at high risk for infection.
• •Latent or active tuberculosis.
• •Major psychiatric disorder that is not adequately controlled by treatment.
• •Epileptic seizures that are not adequately controlled by treatment.
• •Prior history of invasive fungal infections.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.