NCT06890923

Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis

An Open Label, Multicenter Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Tiziana Life Sciences LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Only subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status. All subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.

Detailed description

TILS-021 (NCT06292923) is an ongoing Phase II dose-ranging study, the dosing regimen imitates that employed in the nonclinical studies that is, Monday-Wednesday-Friday for two consecutive weeks and then one rest week. This is believed to optimize the immunologic response to anti-CD3. It will assess the safety and potential efficacy as reflected in microglial activation on the PET scan, neurologic exam and measures, and immunologic changes in response to nasal foralumab administration in a randomized, double-blind, placebo-controlled, multicenter Phase II study of non-active secondary progressive MS patients with three months of treatment. Patients completing TILS-021will be eligible to enroll in study TILS-022. The primary objectives of this study in subjects with non-active secondary progressive multiple sclerosis (SPMS) that have successfully completed study TILS-022 are to evaluate 6-month (Day 169) safety data of nasal foralumab, as assessed by adverse event reports; changes in laboratory values; changes in physical, neurological, or nasal examinations; or changes in Total Nasal Symptom Score (TNSS). Objective 2 is to assess the clinical effect of foralumab after 6 months (Day 169) of treatment relative to baseline, as measured by the Modified Fatigue Impact Scale (MFIS).

Conditions

• Non-Active Secondary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Foralumab TZLS-401 100 µg	Patients meeting the requirements of the dose escalation rules will receive nasal foralumab 100 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles.

Timeline

• Start date: 2025-03-04
• Primary completion: 2026-04-30
• Completion: 2026-08-30
• First posted: 2025-03-24
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study