Back to search results

Nasal Foralumab for Non-Active Secondary Progressive Multiple Sclerosis

This study is testing a drug called nasal foralumab (TZLS-401) for people with non-active secondary progressive multiple sclerosis (SPMS), a type of MS where symptoms worsen over time without clear relapses. You can only join this study if you have already completed a previous study (TILS-021) involving nasal foralumab. The main goals are to check the safety and how well people tolerate the drug over 6 months, and to see if it helps with symptoms like fatigue. Participants will receive nasal foralumab three days a week for two weeks, followed by a one-week break, in repeating cycles. The dose might increase during the study. The study aims to enroll 55 participants.

Study design
This is an open-label extension study, meaning everyone knows they are receiving the active drug. It is designed for about 55 participants who completed a previous study.
What's involved
You would receive nasal foralumab three days a week for two weeks, followed by a one-week rest, in repeating 3-week cycles for 6 months. There will be assessments at the beginning and end of the study, and potentially at other times.
Compensation
Not stated in the trial record.
Follow-up
The study evaluates safety and clinical effects after 6 months (Day 169) of treatment, or at the time of study termination.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06890923

Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Tiziana Life Sciences LTD
~55 participants
Updated 2025-06-06 on ClinicalTrials.gov
What's tested:Foralumab TZLS-401 100 µg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over Day 1 vs Day 169 (end of study)
+5 more outcomes measured

Conditions

Non-Active Secondary Progressive Multiple Sclerosis

Explore related trials

Multiple Sclerosis

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Tiziana
[email protected]
1-833-849-4262
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Subjects must have enrolled in and successfully completed TILS-021 within the preceding 90 days, including End of Treatment and End of Study assessments.
Screening clinical laboratory studies are within the normal ranges or within the parameters specified below, and clinically acceptable in the opinion of the Investigator. Exceptions must be approved by the Clinical Research Organization or Sponsor's Medical Monitor.
Adequate hematologic parameters without ongoing transfusion support:
Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula
Total bilirubin ≤ 1.5 times the ULN unless due to Gilbert's disease.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times ULN.
Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of childbearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months).
Sexually active women of childbearing potential and male patients must agree to use two effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptives; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study, and for 90 days after the completion of study treatment.
Immunizations are current and up to date as adjusted for disease status and prior/current treatments and documented by the subject's treating neurologist.
Ability and willingness to provide written informed consent.

Exclusion

Subjects that terminated TILS-021 early as defined as not undergoing an End of Treatment visit.
Subjects that terminated TILS-021 early as defined as not undergoing an End of Study visit.
Subjects that terminated TILS-021 due to any adverse events.
Corticosteroid use (oral or intravenous) within the last 60 days or anticipated need for such treatment during the study period.
Current use or use within 30 days prior to the Screening Visit of interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate, ponesimod, ozanimod, cyclosporin, methotrexate, azathioprine, mycophenolate mofetil, natalizumab or any other chronic immunosuppressive medication. Concomitant immunomodulatory or immunosuppressant treatments for MS are not permitted during study participation.
Patient in whom the need to start or stop other pharmacologic treatment for MS is expected during the time of the study or the need for initiation of B cell depleting therapies (e.g.: ocrelizumab, ofatumumab, ublituximab, rituximab) during the study.
Use of B cell depleting therapies (e.g.: ocrelizumab, ofatumumab, ublituximab, rituximab) at any time during study TILS-021 or after the patient has completed TILS-021 is not permitted.
Subjects with any previous exposure to alemtuzumab, cyclophosphamide, cladribine, mitoxantrone, or daclizumab.
Prior use of autologous hematopoietic stem cell transplantation or stem cell therapy.
Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 60 days.
Active COVID-19 disease; according to FDA guidelines.
Female patient who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during the study. Female patients of childbearing age will undergo a serum pregnancy test at Screening, but prior to receiving their first dose, and be excluded from the study if positive. Urine pregnancy testing will be carried out prior to each dosing cycle, and the subject's study participation will be stopped if there is a positive result. Pregnancy testing will also be performed prior to each MRI imaging session and participation in the imaging session and the study will be terminated if positive.
Any history of malignancy or active malignancy. This includes any skin cancers at any time.
Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes.
Patients with a history of gadolinium allergy/contraindications or any other contraindications to MRI, such as metal implants, chronic renal disease and an eGRF of \<30 mL/minute or claustrophobia. Or who are unable to lay flat in the PET or MRI scanner for the duration of the studies.
Known positivity for human immunodeficiency virus, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus or tuberculosis at Screening. If the subject has a history of positivity for any of these diseases, they are excluded even if current Screening is negative.
Any nasal pathology such as clinically significant deviated septum, nasal polyps, chronic rhinitis, or a history of sinusitis diagnosed or treated in the past 12 months.
Clinically significant cardiac condition or ECG abnormality at Screening or by history. An ECG will be done prior to each dosing cycle and patients will be excluded or treatment discontinued for any significant ECG abnormality.
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.
Other than nasal foralumab, receipt of an investigational drug/biological product in the past 30 days of Screening, or concurrent receipt of an investigational drug during this study, other than the product under study.

What this trial measures

  • Safety and TolerabilityDay 1 vs Day 169 (end of study)

    The safety and tolerability of 50 µg/dose and 100 µg/doses of foralumab nasal as measured by adverse event reports

  • Change in BaselineDay 1 vs Day 169 (or termination)

    Assess change in baseline Modified Fatigue Impact Scale (MFIS) Scores range from 0-84. 0 is the minimum score and 84 is the maximum score. Lower scores indicate less fatigue while higher scores indicate increased fatigue.

  • Safety and TolerabilityDay 1 vs Day 169 (or termination)

    Blood pressure will be monitored at the beginning of every cycle. Increases and decreases in baseline will be monitored assessed for safety.

  • Safety and TolerabilityDay 1 vs Day 169 (or termination)]

    Heart rate will be monitored at the beginning of every cycle. Increases and decreases in baseline will be monitored assessed for safety.

  • Safety and TolerabilityDay 1 vs Day 169 (or termination)

    Lab values such as CHEM7 and CBC will be monitored at the beginning of every cycle on day 1. Any increases or decreases in baseline lab values will be assessed for safety.

  • Safety and TolerabilityDay 1 vs Day 169 (or termination)

    Total Nasal Symptom Score (TNSS). Scores range from 0-3 where 0 (minimum score) is no symptoms and 3 (maximum score) is severe. Higher scores indicate worse outcome.