Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Multiple Sclerosis AIN457 Secukinumab Magnetic Resonance Imaging Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Nervous System Diseases Immune System Diseases Demyelinating Diseases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

Detailed description:

Arms:
arm 1: AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis. arm 2: Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2). arm 3: AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis arm 4: AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.

Interventions: intervention 1: Placebo intervention 2: AIN457
Intervention descriptions: intervention 1: Placebo will be administered at predefined visits over the 6-month treatment phase. intervention 2: AIN457 will be administered at predefined visits over the 6-month treatment phase.

Protocol document: