Actively Recruiting
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
Led by Tiziana Life Sciences LTD · Updated on 2025-10-15
54
Participants Needed
7
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of MS according to the 2017 McDonald criteria.
- Age 18 years to 75 years.
- Confirmed clinical diagnosis of non-active SPMS for at least 2 years prior to screening.
- MRI imaging consistent with MS at any time point.
- Expanded Disability Status Scale (EDSS) score between 2.5 and 6.5.
- Documented failure of standard disease-modifying therapies for at least 2 years with continued disability progression.
- Screening laboratory tests within specified normal or acceptable ranges.
- Negative pregnancy tests for women of child-bearing potential.
- Agreement to use two effective pregnancy prevention methods during the study and for 90 days after.
- Up-to-date immunizations as documented by neurologist.
- Ability and willingness to provide written informed consent.
You will not qualify if you...
- Use of corticosteroids within 60 days before screening or anticipated use during the study.
- Use of certain immunosuppressive or immunomodulatory treatments within 30 days before screening.
- Need to start or stop other MS treatments or B cell depleting therapies during the study.
- Use of B cell depleting therapies or terifluonimide within the previous 6 months.
- Previous exposure to alemtuzumab, cyclophosphamide, cladribine, mitoxantrone, or daclizumab.
- Prior use of autologous hematopoietic stem cell transplant or stem cell therapy.
- Inability to tolerate nasal medications.
- Use of nasal corticosteroids, antihistamines, or flu dosing within 60 days.
- Active COVID-19 infection.
- Pregnancy, lactation, or planning pregnancy during the study.
- History or active malignancy.
- Certain autoimmune diseases like inflammatory bowel disease, rheumatoid arthritis, lupus, asthma, or type 1 diabetes.
- Contraindications to MRI or PET imaging.
- Low affinity TSPO binder genotype.
- Positive EBV IgM or history of EBV positivity.
- Known HIV, hepatitis B or C, or tuberculosis infection.
- Low neutrophil or lymphocyte counts.
- Significant nasal pathologies.
- Significant cardiac conditions or ECG abnormalities.
- Recent infections or treatment for infections.
- Use of investigational drugs in past 30 days or previous foralumab nasal treatment.
- Any other condition that could interfere with study participation or results interpretation.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Yale
North Haven, Connecticut, United States, 06473
Actively Recruiting
2
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Actively Recruiting
5
University of Buffalo
Buffalo, New York, United States, 14202
Actively Recruiting
6
Cornell Weill Medical Center
New York, New York, United States, 10021
Actively Recruiting
7
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
T
Tiziana
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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