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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients (NCT06292923) is a Phase 2 interventional studying Secondary Progressive Multiple Sclerosis, sponsored by Tiziana Life Sciences LTD. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Secondary Progressive Multiple Sclerosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 54 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Secondary Progressive Multiple Sclerosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

1. Confirmed diagnosis of MS according to the 2017 McDonald criteria . 2. Age 18 years to age 75 years. 3. Confirmed clinical diagnosis of non-active SPMS, for 2 years prior to the screening visit. The baseline study visit and/or the baseline MRI may not be used to confirm the diagnosis but will be used to establish a study baseline and for interpretation of the PET scan data. The second qualifying MRI must be within 3 months of the study screening MRI. 4. MRI imaging consistent with a diagnosis of MS at any time point. 5. Score on the Expanded Disability Status Scale (EDSS) of 2.5-6.5. 6. Have failed standard-of-care treatment with disease-modifying therapies for at least 2 years with continued accumulation of disability as evaluated by treating neurologist. Treatment failure/progression can be defined as EDSS worsening despite best treatment efforts: - EDSS increase by 1.0 (if baseline EDSS between 1.0-5.5) in the past 2 years. - EDSS increase by 0.5 (if baseline EDSS \>6.0) in the past 2 years. 7. 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 CRO or Sponsor's Medical Monitor. - Adequate hematologic parameters without ongoing transfusion support: - Hemoglobin (Hb) ≥9 g/dL - platelet count at least 100 × 10\^9 cells/L - Creatinine ≤1.5 × the upper limit of normal (ULN), or calculated kidney function (creatinine clearance) at least 60 mL/minute × 1.73 m\^2 per the Cockcroft-Gault formula. - Total bilirubin ≤1.5 times the upper limit of normal (ULN) unless due to Gilbert's disease. - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.0 times ULN. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
1. Confirmed diagnosis of MS according to the 2017 McDonald criteria . 2. Age 18 years to age 75 years. 3. Confirmed clinical diagnosis of non-active SPMS, for 2 years prior to the screening visit. The baseline study visit and/or the baseline MRI may not be used to confirm the diagnosis but will be used to establish a study baseline and for interpretation of the PET scan data. The second qualifying MRI must be within 3 months of the study screening MRI. 4. MRI imaging consistent with a diagnosis of MS at any time point. 5. Score on the Expanded Disability Status Scale (EDSS) of 2.5-6.5. 6. Have failed standard-of-care treatment with disease-modifying therapies for at least 2 years with continued accumulation of disability as evaluated by treating neurologist. Treatment failure/progression can be defined as EDSS worsening despite best treatment efforts: * EDSS increase by 1.0 (if baseline EDSS between 1.0-5.5) in the past 2 years. * EDSS increase by 0.5 (if baseline EDSS \>6.0) in the past 2 years. 7. 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 CRO or Sponsor's Medical Monitor. * Adequate hematologic parameters without ongoing transfusion support: * Hemoglobin (Hb) ≥9 g/dL * Platelets ≥100 × 10\^9 cells/L * Creatinine ≤1.5 × the upper limit of normal (ULN), or calculated creatinine clearance ≥60 mL/minute × 1.73 m\^2 per the Cockcroft-Gault formula. * Total bilirubin ≤1.5 times the upper limit of normal (ULN) unless due to Gilbert's disease. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.0 times ULN. 8. Negative serum pregnancy test at screening and negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of child-bearing 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). 9. Sexually active women of child-bearing potential and male patients must agree to use 2 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. 10. Immunizations are current and up-to-date as adjusted for disease status and prior/current treatments, and documented by the patient's treating neurologist. 11. Ability and willingness to provide written informed consent. Exclusion Criteria: 1. Corticosteroid use (oral or intravenous) within the last 60 days or anticipated need for such treatment during the study period. 2. 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. 3. 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, rituximab) during the study. 4. Use of B cell depleting therapies (e.g. ocrelizumab, ofatumumab, rituximab) within the prior 6 months. Or use of terifluonimide within the previous 6 months. 5. Patients with any previous exposure to alemtuzumab, cyclophosphamide, cladribine, mitoxantrone, or daclizumab. 6. Prior use of AHSCT or stem cell therapy. 7. Inability to tolerate nasally administered medications. 8. Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 60 days. 9. Active COVID-19 disease; according to FDA guidelines. 10. 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 and be excluded from the study if positive. Urine pregnancy testing will be carried out prior to each dosing cycle, and the patient's study participation will be stopped if there is a positive result. Pregnancy testing will also be performed prior to each MRI or PET imaging session and participation in the imaging session and the study will be terminated if positive. 11. Any history of malignancy or active malignancy. 12. Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes. 13. Patients with a history of gadolinium allergy 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. 14. A low affinity translocator protein (TSPO) binder (for PET ligand \[18F\]PBR06) determined by having a Thr/Thr polymorphism in the TSPO gene at screening. 15. EBV IgM-positive patients, assessed at screening. Patients will also be excluded if they have a documented history of being EBV positive, even if the testing at screening is negative. 16. Known positivity for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) or tuberculosis at screening. If the patient has a history of positivity for any of these diseases, they are excluded even if current screening is negative. 17. Patients with a neutrophil count at baseline of \<1000 cells/mL or lymphocytes \<500 cells/mL. 18. 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. 19. 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. 20. 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. 21. A history of recent infections or treatment for infections. 22. Receipt of an investigational drug/biological product in the past 30 days of screening, or concurrent receipt of an investigational during this study, other than the product under study. Patients may not have previously received treatment with foralumab nasal.

Treatments Being Tested

DRUG

Foralumab

Foralumab nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare). Each Unidose device contains foralumab nasal solution, supplied at either 25 μg foralumab or 50 μg foralumab, sufficient for administration into a single nare.

OTHER

Placebo

Foralumab placebo nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare).

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Yale
North Haven, Connecticut, United States
Johns Hopkins
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Buffalo
Buffalo, New York, United States
Cornell Weill Medical Center
New York, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06292923), the sponsor (Tiziana Life Sciences LTD), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06292923 clinical trial studying?

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 fr… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06292923?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06292923?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06292923. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06292923. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.