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Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS

Multiple Sclerosis Clinical Trial

Official title:
A Phase 1b, Double-Blind, Randomized, Placebo Controlled, Multiple Ascending Dose Study of the Safety, Tolerability and Immune Effects of the Intranasal Anti-CD3 Monoclonal Antibody Foralumab in Primary and Secondary Progressive MS

Clinical Trial Summary

The primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.

Clinical Trial Description

This is a Phase 1b double blind, randomized, placebo controlled, dose escalating study evaluating multiple doses of Foralumab via intranasal administration for 14 days in patients with MS. Up to 55 untreated primary and secondary progressive MS patients will be enrolled, to obtain a total of 48 completed subjects (9 active, 3 placebos per group), allowing for dropouts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05029609
Study type Interventional
Source Tiziana Life Sciences, PLC
Contact
Status Withdrawn
Phase Phase 1
Start date October 2021
Completion date December 2022
View Details
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