Conditions: Relapse Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis Magnetic Resonance Imaging VAY736 Lanalumab monoclonal antibody gadolinium [Gd]-enhancing lesions B-Cell
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8
Healthy volunteers: no

Brief summary:
This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).

Detailed description:
The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.

Arms:
arm 1: Intravenous infusion of VAY736 arm 2: Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16

Interventions: intervention 1: VAY736 intervention 2: Placebo
Intervention descriptions: intervention 1: Single intravenous infusion of VAY736 (10 mg/kg) intervention 2: Placebo to VAY736

Protocol document: