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

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.

NCT Number	NCT06890923
Lead Sponsor	Tiziana Life Sciences LTD
Conditions	Non-Active Secondary Progressive Multiple Sclerosis
Enrollment	55 participants
Start Date	2025-03-04
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-08-30 (estimated)
Updated on ClinicalTrials.gov	2025-06-06