A Study of Nasal Foralumab for Secondary Progressive Multiple Sclerosis
This study is testing a nasal spray called foralumab for people with non-active secondary progressive multiple sclerosis (SPMS). Foralumab is a monoclonal antibody (a type of protein that can target specific cells) that may help with autoimmune diseases. Researchers want to see if foralumab is safe and how well it's tolerated at two different doses (50 μg/dose and 100 μg/dose) compared to a placebo (an inactive spray). They will also look at changes in brain inflammation using special PET scans. You may be able to join if you are 18-75 years old and have a confirmed diagnosis of non-active SPMS. The study aims to enroll 54 participants, but its current recruitment status is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either foralumab or a placebo, and neither you nor your doctor will know which you are receiving. The study plans to enroll 54 participants.
- What's involved
- You would receive the nasal spray three days a week for two weeks, followed by a one-week rest, for a total of four cycles (12 weeks). You would also have PET scans before and after this treatment period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured throughout the study, for an average of 12 weeks (3 months). Brain inflammation will be measured after 12 weeks of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
At a glance
Conditions
NCT06292923
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Brigham and Women's Hospital
Boston, Massachusettsno site contact published
Cornell Weill Medical Center
New York, New Yorkno site contact published
Johns Hopkins
Baltimore, Marylandno site contact published
Thomas Jefferson University Hospital
Philadelphia, Pennsylvaniano site contact published
University of Buffalo
Buffalo, New Yorkno site contact published
University of Massachusetts
Worcester, Massachusettsno site contact published
Yale
North Haven, Connecticutno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- The number of patients with adverse event (AE) reports.Throughout the study, an average of 12 weeks (3 months).
- Changes in the Total Nasal Symptom Score (TNSS).TNSS is performed during the Screening Visit and during the Treatment Period at the first visit of Cycle 1, Cycle 2, Cycle 3, and Cycle 4 (each Cycle is 3 weeks).
The TNSS is the sum of scores over 24 hours and 2 weeks for nasal congestion, runny nose, nasal itching, sneezing, and difficulty sleeping. The TNSS is quantified using the following scale: None 0, Mild 1 (symptom clearly present but easily tolerated), Moderate 2 (symptom bothersome but tolerable), Severe 3 (symptom difficult to tolerate - interferes with activities).
- Change from baseline for [18F]PBR06-positron emission tomography (PET) scans for microglial activation after 12 weeks (3 months) of study treatment.Subjects will undergo PET imaging prior to Week 1 (i.e., prior to dosing) and after Week 12 (after Cycle 4 at the PET sub-study site).
Subjects at all sites will undergo PET imaging with the radiotracer \[18F\]PBR06.