Secondary Progressive Multiple Sclerosis Clinical Trial
Official title:
A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
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.
Multiple sclerosis (MS) is a common autoimmune disorder affecting young adults, driven by an aberrant T cell response against central nervous system (CNS) antigens. Epidemiologic studies show that approximately 50% of patients are classified as having relapsing-remitting multiple sclerosis (RRMS), while about 35% have SPMS and the remaining 15% have primary progressive MS (PPMS). Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. It is hypothsized that nasal foralumab will slow disability accumulation and microglial activation measured by PET imaging in non-active SPMS. This study is a randomized, double-blind, placebo-controlled, multicenter, parallel-group study of 2 doses of nasal foralumab (50 μg/dose or 100 μg/dose of foralumab nasal) compared to placebo in the treatment of non-active SPMS for 3 months (4 three-week cycles of treatment). Fifty-four subjects with non-active SPMS will be randomized 1:1:1 to one of three treatment cohorts: 1. Group A: Nasal foralumab 50 μg 3 days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising a 3-week cycle, for a total of four cycles. 2. Group B: Nasal foralumab 100 μg 3 days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising a 3-week cycle, for a total of four cycles. 3. Group C: Nasal placebo (acetate buffer) 3 days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising a 3-week cycle, for a total of four cycles. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04239664 -
Acceptance Based Telephone Support When Transitioning to SPMS
|
N/A | |
| Active, not recruiting |
NCT04411641 -
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
|
Phase 3 | |
| Completed |
NCT02549703 -
Mitochondrial Dysfunction and Disease Progression
|
||
| Terminated |
NCT01416181 -
A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis
|
Phase 3 | |
| Withdrawn |
NCT01181089 -
Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03471338 -
Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
|
N/A | |
| Withdrawn |
NCT05029609 -
Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS
|
Phase 1 | |
| Completed |
NCT02228213 -
Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis
|
Phase 2 | |
| Terminated |
NCT02296346 -
Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis
|
N/A | |
| Completed |
NCT00559702 -
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
|
Phase 1 | |
| Terminated |
NCT03283826 -
Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis
|
Phase 1/Phase 2 | |
| Completed |
NCT02253264 -
A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients
|
Phase 1 | |
| Completed |
NCT01737372 -
A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
|
N/A | |
| Completed |
NCT00257855 -
A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis
|
Phase 2 | |
| Active, not recruiting |
NCT01228396 -
AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT03896217 -
Simvastatin in Secondary Progressive Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT02495766 -
Autologous Mesenchymal Stromal Cells for Multiple Sclerosis
|
Phase 1/Phase 2 | |
| Completed |
NCT00813969 -
Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
|
Phase 1 | |
| Completed |
NCT01077466 -
Natalizumab Treatment of Progressive Multiple Sclerosis
|
Phase 2 | |
| Terminated |
NCT00146159 -
Study Evaluating Mitoxantrone in Multiple Sclerosis
|
Phase 3 |