A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

Summary

Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS). The primary objectives that this study aims to answer are: 1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo 2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.

Timeline

Start

2023-11-15

Primary completion

2026-09

Completion

2026-10

Publications

• Background Nasal anti-CD3 monoclonal antibody (Foralumab) reduces PET microglial activation and blood inflammatory biomarkers in a patient with non-active secondary progressive MS. 2022, The Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, National Harbor, MD, US.
• Background Nasal anti-CD3 monoclonal antibody (Foralumab) reduces PET microglial activation and blood inflammatory biomarkers in two patients with non-active secondary progressive multiple sclerosis. 2022, European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Congress, Amsterdam, ND.
• Background Treatment of six non-active secondary progressive MS patients with nasal anti-CD3 monoclonal antibody (Foralumab): safety, biomarker, and disability outcomes. 2023, European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Congress, Milan, IT.
• Background Treatment of PIRA with nasal foralumab dampens microglial activation and stabilizes clinical progression in non-active secondary progressive MS. 2024, American Academy of Neurology (AAN) Annual Meeting, Denver, CO, US.

Drugs

Indications