Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
brief 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).
official title
An Open Label, Multicenter Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients