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A Phase 1b, Double-Blind, Randomized, Placebo Controlled, Multiple Ascending Dose Study of the Safety, Tolerability and Immune Effects of the Intranasal Anti-CD3 Monoclonal Antibody Foralumab in Primary and Secondary Progressive MS
The primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.
Details
| Lead sponsor | Tiziana Life Sciences LTD |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2021-10 |
| Completion | 2022-12 |
Conditions
- Primary Progressive Multiple Sclerosis
- Secondary Progressive Multiple Sclerosis
- Multiple Sclerosis
Interventions
- Intranasal Foralumab Solution
- Placebo
Primary outcomes
- To establish the safety of intranasal foralumab in non-active primary and secondary progressive MS in escalating doses for 14 consecutive days — 14 days
Analyses through review of adverse events categorized and graded via CTCAE.