At a glance
ClinicalIndex Comparison Record- ✓Confirmed MS diagnosis per 2017 McDonald criteria
- ✓Age 18-75 years
- ✓Non-active SPMS for ≥2 years prior to screening
- ✓EDSS score 2.5-6.5
- ✕Corticosteroid use (oral or IV) within 60 days
- ✕Immunomodulatory/immunosuppressant agents within 30 days
- ✕B-cell depleting therapies within 6 months
- ✕Teriflunomide within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06292923Phase 2RecruitingUpdate OverdueUpdated 8mo ago · Completion was 7mo agoA Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
In Brief
A Phase 2 clinical trial evaluating Foralumab and Placebo for Secondary Progressive Multiple Sclerosis. Currently recruiting, targeting 54 participants across 7 sites.
Signals
Detailed Summary
Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS). The primary objectives that this study aims to answer are: 1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo 2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.
Study Details
Timeline
Interventions
Foralumab nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare). Each Unidose device contains foralumab nasal solution, supplied at either 25 μg foralumab or 50 μg foralumab, sufficient for administration into a single nare.
Foralumab placebo nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare).