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

Conditions

• Non-Active Secondary Progressive Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Foralumab TZLS-401 100 µg — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 4, 2025

Status verified

Mar 2025

Primary completion

Apr 30, 2026

Completion

Aug 30, 2026

Study Design

Enrollment

55 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Nasal foralumab 50 μg per dosing day (25 μg per nostril)
  All patients will initially receive nasal foralumab 50 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles.

Primary Outcome Measure

Safety and Tolerability [ Time Frame: Day 1 vs Day 169 (end of study) ]

Central Contacts

• Tiziana
  1-833-849-4262
  [email protected]

Locations (1)

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