Phase 2a Study of Nasal Foralumab Treatment in Adults 30 to 85 Years With Multiple System Atrophy MSA Evaluating Safety, Brain Immune Activity, and Clinical Effects

What this Trial Is About

This trial investigates the use of Foralumab Nasal in adults aged 30 to 85 years diagnosed with Multiple System Atrophy MSA, a progressive neurological disorder. It is a Phase 2a study focusing on evaluating microglial activation, safety, and clinical effects of the treatment in this patient population. The study includes patients with clinically established or probable MSA under stable dopaminergic treatment. Participants will first enter a 6-month observational lead-in phase without active treatment, followed by a 6-month open-label treatment phase. During treatment, Foralumab, an anti-CD3 monoclonal antibody delivered as a nasal spray, will be given in eight 3-week cycles. Each cycle involves intranasal doses three times per week for two weeks, then a one-week break. Throughout the study, participants will undergo assessments including motor function exams, quality of life questionnaires, brain imaging to measure inflammation and volume changes, and blood tests to monitor safety. Researchers will measure changes in MDS-UMSARS scores and TSPO activity using PET scans over six months. The total participation time is approximately one year including both observation and treatment periods.

A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)