Actively Recruiting
A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying nasal foralumab, a human anti-CD3 monoclonal antibody, for treating non-active secondary progressive multiple sclerosis (SPMS), a form of multiple sclerosis affecting adults. This Phase 2a randomized, double-blind, placebo-controlled, multicenter trial aims to assess the safety and tolerability of two dosages of nasal foralumab and its effect on microglial activation in the brain, measured by PET scans after 12 weeks of treatment. Participants will be randomly assigned to one of three groups: nasal foralumab 50 µg, nasal foralumab 100 µg, or nasal placebo. Each dose is given three days a week (Monday, Wednesday, Friday) for two weeks followed by a one-week rest, making a 3-week cycle. This cycle is repeated four times over three months. The nasal solution is administered via a nasal atomizer device, with each dose split evenly between nostrils. Throughout the study, participants undergo assessments including PET scans, MRI, disability scales, fatigue impact, and nasal symptom scoring at baseline and during treatment cycles. Safety is monitored by tracking adverse events and laboratory tests. The study lasts about 12 weeks, during which researchers will evaluate changes in microglial activity and disability, as well as the safety and tolerability of the nasal foralumab treatment.
CONDITIONS
Brief 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 multiple sclerosis according to the 2017 McDonald criteria.
- Age between 18 and 75 years.
- Confirmed clinical diagnosis of non-active secondary progressive multiple sclerosis for at least 2 years before screening.
- MRI imaging consistent with multiple sclerosis at any time.
- Expanded Disability Status Scale (EDSS) score between 2.5 and 6.5.
- Have failed standard disease-modifying therapies for at least 2 years with continued disability progression.
- Clinical lab studies within acceptable ranges or approved exceptions.
- Negative pregnancy tests for women of child-bearing potential before treatment.
- Agreement to use two effective pregnancy prevention methods during and 90 days after the study for sexually active participants.
- Up-to-date immunizations as documented by treating neurologist.
- Ability and willingness to provide written informed consent.
You will not qualify if you...
- Use of corticosteroids within 60 days before screening or planned during the study.
- Use of certain immunosuppressive or immunomodulatory drugs within 30 days before screening.
- Expected need to start or stop other MS treatments during the study.
- Use of B cell depleting therapies or teriflunomide within the past 6 months.
- Prior exposure to specific immunosuppressive drugs or stem cell therapies.
- Inability to tolerate nasal medications.
- Use of nasal corticosteroids, antihistamines, or flu vaccines in the past 60 days.
- Active COVID-19 infection.
- Pregnancy, breastfeeding, or planning pregnancy during the study.
- History or presence of malignancy.
- Certain autoimmune diseases like rheumatoid arthritis or lupus.
- Contraindications to MRI or PET imaging, such as metal implants or severe claustrophobia.
- Low affinity TSPO binders for PET scans.
- Positive for certain infections including HIV, hepatitis B or C, tuberculosis, or EBV IgM.
- Low neutrophil or lymphocyte counts.
- Significant nasal pathology or recent sinus infections.
- Significant cardiac conditions or ECG abnormalities.
- Any condition that could interfere with study adherence or results.
- Recent infections or investigational drug use.
- Previous treatment with foralumab nasal.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months (4 cycles of 3 weeks each)
Participants receive nasal foralumab or placebo 3 days a week (Monday, Wednesday, Friday) for two weeks, followed by a one-week rest, in 3-week cycles repeated for four cycles over 3 months.
Visits at the first day of each 3-week cycle (4 visits total) plus dosing visits 3 days per week in each cycle
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
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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