RecruitingPhase 2NCT06292923

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

A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

Sponsor

Tiziana Life Sciences LTD

Enrollment

54 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

Secondary Progressive Multiple Sclerosis

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing nasal (inhaled through the nose) foralumab — an immune-modulating drug — in people with non-active secondary progressive multiple sclerosis (SPMS). SPMS is a stage of MS where the disease slowly worsens without distinct relapses. The nasal route may help calm the immune response while limiting side effects. **You may be eligible if...** - You are between 18 and 75 years old with confirmed MS (2017 McDonald criteria) - You have had non-active SPMS for at least 2 years (no new relapses or MRI lesion activity) - Your disability score is between 2.5 and 6.5 on the EDSS scale - Standard MS disease-modifying treatments have failed for at least 2 years **You may NOT be eligible if...** - You have active SPMS (recent relapses or new MRI lesions) - You have relapsing-remitting MS or primary progressive MS - You have significant other medical conditions or are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGForalumab

Foralumab nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare). Each Unidose device contains foralumab nasal solution, supplied at either 25 μg foralumab or 50 μg foralumab, sufficient for administration into a single nare.

OTHERPlacebo

Foralumab placebo nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare).