NCT05029609

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tiziana Life Sciences LTD · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Progressive Multiple Sclerosis
• Secondary Progressive Multiple Sclerosis
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Intranasal Foralumab Solution	The Aptar Unidose device will be used to deliver foralumab nasal solution intranasally. Foralumab nasal solution is prepackaged in a Type 1 glass vial inside the Unidose device.
DRUG	Placebo	The placebo nasal solution is the acetate buffer vehicle used for foralumab nasal solution. It will be handled in a manner identical to active drug.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2021-08-31
• Last updated: 2022-03-03

Regulatory

• FDA-regulated drug study