Actively Recruiting
Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
Led by Tiziana Life Sciences LTD · Updated on 2025-06-06
55
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Only subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status. All subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.
CONDITIONS
Official Title
Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have successfully completed the TILS-021 study within the past 90 days, including End of Treatment and End of Study assessments
- Clinical lab tests must be within normal or acceptable ranges
- Hemoglobin level of at least 9 g/dL
- Platelet count of at least 100 x 10^9 cells/L
- Creatinine level at or below 1.5 times the upper limit of normal or creatinine clearance of at least 60 mL/min/1.73 m2
- Total bilirubin at or below 1.5 times the upper limit of normal unless due to Gilbert's disease
- ALT and AST at or below 2.0 times the upper limit of normal
- Negative urine pregnancy test within 7 days prior to first dose for women of childbearing potential
- Sexually active women of childbearing potential and male patients must agree to use two effective contraception methods during the study and for 90 days after
- Immunizations must be current and documented
- Able and willing to provide written informed consent
You will not qualify if you...
- Did not complete the End of Treatment or End of Study visits in TILS-021
- Terminated TILS-021 due to adverse events
- Used corticosteroids (oral or IV) within 60 days before the study or expect to need them during the study
- Used interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate, ponesimod, ozanimod, cyclosporin, methotrexate, azathioprine, mycophenolate mofetil, natalizumab, or other chronic immunosuppressive drugs within 30 days before screening
- Expected to start or stop other MS pharmacologic treatments or B cell depleting therapies during the study
- Previous or current use of B cell depleting therapies during or after TILS-021
- Previous exposure to alemtuzumab, cyclophosphamide, cladribine, mitoxantrone, or daclizumab
- Prior autologous hematopoietic stem cell transplant or stem cell therapy
- Used nasal corticosteroids, antihistamines, or flu dosing within 60 days
- Active COVID-19 infection
- Pregnant, lactating, breastfeeding, or planning pregnancy during the study
- History or active malignancy including skin cancers
- History of inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes
- Contraindications to MRI including gadolinium allergy, metal implants, severe kidney disease, or claustrophobia
- Positive for HIV, hepatitis B or C, or tuberculosis at screening or history of these infections
- Nasal pathology such as significant deviated septum, nasal polyps, chronic rhinitis, or recent sinusitis
- Significant cardiac condition or ECG abnormalities
- Any condition or intervention that could affect adherence or study results
- Received investigational drugs other than nasal foralumab within 30 days before screening or during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
T
Tiziana
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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