Calendario›TLSA›Foralumab TZLS-401 100 µg · TILS-022

Foralumab TZLS-401 100 µg · TILS-022

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

Ensayo de Tiziana Life Sciences Ltd en Non-Active Secondary Progressive Multiple Sclerosis (del registro, en inglés).

Fase

Fase 2

Estado

Reclutando pacientes

Participantes

55

previstos

Centros

1

Fin del objetivo primario

abr 2026

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2025.

Qué mide

Safety and Tolerability (Day 1 vs Day 169 (end of study)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroOnly 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.

Más ensayos de TLSA

Todos los de TLSA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06890923), actualizada en jun 2025.