Clinical Trial

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

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2024-02-27; most recent amendment 2026-06-30.
Status change: Recruiting → Active, Not Recruiting 2026-06-30
Trial Details
NCT Number NCT06292923
Lead Sponsor Tiziana Life Sciences LTD
Conditions Secondary Progressive Multiple Sclerosis
Enrollment 54 participants
Start Date 2023-11-15
Primary Completion 2026-09 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-02