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.

Conditions

• Non-Active Secondary Progressive Multiple Sclerosis

Intervention / Treatment

• Drug: Foralumab TZLS-401 100 µg

Primary Outcome Measures

• Safety and Tolerability (Day 1 vs Day 169 (end of study))
  The safety and tolerability of 50 µg/dose and 100 µg/doses of foralumab nasal as measured by adverse event reports
• Change in Baseline (Day 1 vs Day 169 (or termination))
  Assess change in baseline Modified Fatigue Impact Scale (MFIS) Scores range from 0-84. 0 is the minimum score and 84 is the maximum score. Lower scores indicate less fatigue while higher scores indicate increased fatigue.
• Safety and Tolerability (Day 1 vs Day 169 (or termination))
  Blood pressure will be monitored at the beginning of every cycle. Increases and decreases in baseline will be monitored assessed for safety.
• Safety and Tolerability (Day 1 vs Day 169 (or termination)])
  Heart rate will be monitored at the beginning of every cycle. Increases and decreases in baseline will be monitored assessed for safety.
• Safety and Tolerability (Day 1 vs Day 169 (or termination))
  Lab values such as CHEM7 and CBC will be monitored at the beginning of every cycle on day 1. Any increases or decreases in baseline lab values will be assessed for safety.
• Safety and Tolerability (Day 1 vs Day 169 (or termination))
  Total Nasal Symptom Score (TNSS). Scores range from 0-3 where 0 (minimum score) is no symptoms and 3 (maximum score) is severe. Higher scores indicate worse outcome.

Countries

United States

Locations and Investigators

• Brigham and Women's Hospital, Boston, United States (Recruiting)
  • Project Manager
  • Tanuja Chitnis (Principal Investigator)