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Non-Active Secondary Progressive Multiple SclerosisPhase 2TILS-022NCT06890923

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

A Phase 2 study testing Foralumab TZLS-401 100 µg in people with Non-Active Secondary Progressive Multiple Sclerosis, run by Tiziana Life Sciences LTD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Foralumab TZLS-401 100 µg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
4 Mar 2025to 30 Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Hemoglobin (Hb) ≥ 9 g/dL
  • Platelets ≥ 100 x 109 cells/L
  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Project Manager, 8338494262, ms@tizianalifesciences.com

    Tanuja Chitnis

    Recruiting

Other trials in United States

About this study

Official title: An Open Label, Multicenter Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

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.

Read the detailed description

TILS-021 (NCT06292923) is an ongoing Phase II dose-ranging study, the dosing regimen imitates that employed in the nonclinical studies that is, Monday-Wednesday-Friday for two consecutive weeks and then one rest week. This is believed to optimize the immunologic response to anti-CD3. It will assess the safety and potential efficacy as reflected in microglial activation on the PET scan, neurologic exam and measures, and immunologic changes in response to nasal foralumab administration in a randomized, double-blind, placebo-controlled, multicenter Phase II study of non-active secondary progressive MS patients with three months of treatment. Patients completing TILS-021will be eligible to enroll in study TILS-022. The primary objectives of this study in subjects with non-active secondary progressive multiple sclerosis (SPMS) that have successfully completed study TILS-022 are to evaluate 6-month (Day 169) safety data of nasal foralumab, as assessed by adverse event reports; changes in laboratory values; changes in physical, neurological, or nasal examinations; or changes in Total Nasal Symptom Score (TNSS). Objective 2 is to assess the clinical effect of foralumab after 6 months (Day 169) of treatment relative to baseline, as measured by the Modified Fatigue Impact Scale (MFIS).

Being tested
Foralumab TZLS-401 100 µg
Keywords
Non-Active Secondary Progressive Multiple Sclerosis, Multiple Sclerosis, Foralumab, phase 2
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foralumab TZLS-401 100 µgDrug

    Patients meeting the requirements of the dose escalation rules will receive nasal foralumab 100 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles.

Study groups in NCT06890923
Study groupRoleWhat they receive
Nasal foralumab 50 μg per dosing day (25 μg per nostril)ExperimentalAll patients will initially receive nasal foralumab 50 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles.
Receives: Drug: Foralumab TZLS-401 100 µg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

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

    Measured: Day 1 vs Day 169 (end of study)

  2. Change in Baseline

    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.

    Measured: Day 1 vs Day 169 (or termination)

  3. Safety and Tolerability

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

    Measured: Day 1 vs Day 169 (or termination)

  4. Safety and Tolerability

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

    Measured: Day 1 vs Day 169 (or termination)]

  5. Safety and Tolerability

    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.

    Measured: Day 1 vs Day 169 (or termination)

  6. Safety and Tolerability

    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.

    Measured: Day 1 vs Day 169 (or termination)

Secondary outcomes (3)
  1. Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue

    Assess change in baseline PROMIS Fatigue Short Form 7a. Scores range from 0-35 where the lower number indicated less fatigue.

    Measured: Day 1 of study vs End of Study (Day 169) or Early Termination

  2. Baseline Neurostatus Expanded Disability Status Scale (EDSS)

    Assess change in baseline Neurostatus EDSS. Scores range from 0-10 where the lower number indicates less disability.

    Measured: Day 1 of study vs End of Study (Day 169) or Early Termination.

  3. Baseline Multiple Sclerosis Functional Composite (MSFC-4)

    Assess change in baseline Multiple Sclerosis functional composite (MSFC-4)

    Measured: Day 1 of study vs End of Study (Day 169) or Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start4 Mar 2025
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All patients will initially receive nasal foralumab 50 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles. Patients meeting the requirements of the dose escalation rules will receive nasal foralumab 100 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles.
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06890923
Sponsor's protocol ID
IND 134155
Acronym
TILS-022
Status last verified
Mar 2025
First submitted
12 Feb 2025
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Foralumab TZLS-401 100 µg in people with Non-Active Secondary Progressive Multiple Sclerosis, run by Tiziana Life Sciences LTD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tiziana (1-833-849-4262, ms@tizianalifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: Day 1 vs Day 169 (end of study)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.

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