NCT06802328

Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients

An Intermediate-Size Patient Population Expanded Access Treatment Protocol Evaluating the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Non-Active Secondary Progressive MS Patients Foralumab Nasal

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Tiziana Life Sciences LTD · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibility of increasing to 100 µg/dosing day. The goal of this expanded access clinical trial is to evaluate safety, tolerability, and immune effects of intranasal Foralumab in non-active secondary progressive multiple sclerosis patients. The primary objective is to treat patients who have failed current available therapy. Participants will visit the clinic for testing and follow-up every cycle (3 weeks) while administering the medication at home if able three times weekly.

Detailed description

Multiple sclerosis (MS) is a common autoimmune disorder affecting young adults, driven by an aberrant T cell response against central nervous system (CNS) antigens. Epidemiologic studies show that approximately 50% of patients are classified as having relapsing-remitting multiple sclerosis (RRMS), while about 35% have SPMS and the remaining 15% have primary progressive MS (PPMS). Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. It is hypothesized that nasal Foralumab will slow disability accumulation and microglial activation measured by PET imaging in non-active SPMS. Patients will be dosed in 3-week cycles, with Foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". This study will assess the safety of nasal Foralumab given over 6 months to non-active secondary progressive MS patients who have failed currently available treatments including the standard of care therapy, Ocrevus (ocrelizumab).

Conditions

• Non-Active Secondary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Foralumab TZLS-401 50 µg	Foralumab 50 µg/dosing day for patients who have failed current therapies. Patients will be dosed in 3-week cycles, with foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". Patients will receive Day 1 doses of nasal foralumab under supervision at the Center for Clinical Investigation at BWH.

Timeline

• First posted: 2025-01-31
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States