Non-Active Secondary Progressive Multiple SclerosisNCT06802328
Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients
A study testing Foralumab TZLS-401 50 µg in people with Non-Active Secondary Progressive Multiple Sclerosis, run by Tiziana Life Sciences LTD at 1 site in United States.
Trial summary
This is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibility of increasing to 100 µg/dosing day. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Non-Active Secondary Progressive Multiple Sclerosis
- What is being tested?
- Foralumab TZLS-401 50 µg
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of MS (according to the 2010 McDonald criteria).
- Age 25-75 years old.
- Clinical diagnosis of non-active SPMS, as defined by the absence of relapses for 2 years.
- MRI imaging consistent with a diagnosis of MS at any time point.
- Score on the Expanded Disability Status Scale (EDSS) of 2.5-7.5.
- Have failed standard of care treatment and continued to decline clinically for at least 6 months.
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- 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.
- Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN.
- QT interval corrected for rate (QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening
- Negative urine pregnancy test within 7 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), 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 WCBP and male patients must agree to use highly effective methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; 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.
- Patients whose immunizations are fully up to date at the Screening, according to the assessment of their primary care physician and neurologist.
- Ability to provide written informed consent.
Who cannot join
- Need for corticosteroid treatment (oral or intravenous) within the past 30 days or anticipated need within 30 days of foralumab therapy initiation.
- Treatment with Ocrevus® (ocrelizumab), Rituxun® (rituximab), Kesimpta® (ofatumumab), Truxima® (rituximab-abbs) within the past 90 days.
- Treatment with Lemtrada® (alemtuzumab) and Mavenclad® (cladribine) within the past 1 year.
- Treatment with chronic immunosuppressives such as interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate or natalizumab within the past 90 days.
- Inability to tolerate nasally administered medications.
- Nasal corticosteroids, nasal antihistamines, nasal flu dosing within the past 30 days, or anticipated need during the study.
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- Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past 8 months.
- Active COVID-19 disease.
- COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing).
- Female patient who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.
- Female patients of childbearing age will undergo a pregnancy test and be excluded from the study if positive.
- Active malignancy within 5 years.
- Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes.
- Neutropenia or an absolute neutrophil count of < 1,000 cells/mL or other indicators of severe immunosuppression.
- Patients with a history of gadolinium allergy.
- Screening labs outside of the normal range; EBV IgM positive patients with clinical signs will not receive study drug.
- Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina, or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV or hereditary long QT syndrome.
- Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, except for antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
- Patients who test positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) at the Screening Visit.
- A recent clinically significant active infection requiring treatment with antibiotics or other anti-infective agents within the past 15 days.
- Patients whose immunizations are not fully up to date at the Screening Visit, as assessed by their primary care physician and neurologist.
- 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.
- Unable or unwilling to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Research Coordinator, 8338494262, ms@tizianalifesciences.com
Tanuja Chitnis
About this study
Official title: An Intermediate-Size Patient Population Expanded Access Treatment Protocol Evaluating the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Non-Active Secondary Progressive MS Patients Foralumab Nasal
This is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibility of increasing to 100 µg/dosing day. The goal of this expanded access clinical trial is to evaluate safety, tolerability, and immune effects of intranasal Foralumab in non-active secondary progressive multiple sclerosis patients. The primary objective is to treat patients who have failed current available therapy. Participants will visit the clinic for testing and follow-up every cycle (3 weeks) while administering the medication at home if able three times weekly.
Read the detailed description
Multiple sclerosis (MS) is a common autoimmune disorder affecting young adults, driven by an aberrant T cell response against central nervous system (CNS) antigens. Epidemiologic studies show that approximately 50% of patients are classified as having relapsing-remitting multiple sclerosis (RRMS), while about 35% have SPMS and the remaining 15% have primary progressive MS (PPMS).
Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. It is hypothesized that nasal Foralumab will slow disability accumulation and microglial activation measured by PET imaging in non-active SPMS.
Patients will be dosed in 3-week cycles, with Foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". This study will assess the safety of nasal Foralumab given over 6 months to non-active secondary progressive MS patients who have failed currently available treatments including the standard of care therapy, Ocrevus (ocrelizumab).
- Being tested
- Foralumab TZLS-401 50 µg
- Keywords
- multiple sclerosis, non-active secondary progressive multiple sclerosis, MS, expanded access, anti-cd3 monoclonal antibody, foralumab, nasal
- 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 50 µgDrug
Foralumab 50 µg/dosing day for patients who have failed current therapies. Patients will be dosed in 3-week cycles, with foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". Patients will receive Day 1 doses of nasal foralumab under supervision at the Center for Clinical Investigation at BWH.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Active Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Tiziana Life Sciences LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802328
- Sponsor's protocol ID
- 161148
- Status last verified
- Mar 2025
- First submitted
- 23 Jan 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intermediate-Size Patient Population Expanded Access Treatment Protocol Evaluating the Safety, Tolerability and Immune Effects of the Nasal Anti-CD3 Monoclonal Antibody Foralumab in Non-Active Secondary Progressive MS Patients Foralumab Nasal
- ClinicalTrials.gov ID
- NCT06802328
- Acronym / sponsor ID
- 161148
- Keywords
- multiple sclerosis, non-active secondary progressive multiple sclerosis, MS, expanded access, anti-cd3 monoclonal antibody, foralumab, nasal
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Tiziana Life Sciences LTDIndustry (pharma, biotech, devices)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, intermediate-size patient population expanded access treatment study utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibility of increasing to 100 µg/dosing day. The goal of this expanded access clinical trial is to evaluate safety, tolerability, and immune effects of intranasal Foralumab in non-active secondary progressive multiple sclerosis patients. The primary objective is to treat patients who have failed current available therapy. Participants will visit the clinic for testing and follow-up every cycle (3 weeks) while administering the medication at home if able three times weekly.
Detailed description
Multiple sclerosis (MS) is a common autoimmune disorder affecting young adults, driven by an aberrant T cell response against central nervous system (CNS) antigens. Epidemiologic studies show that approximately 50% of patients are classified as having relapsing-remitting multiple sclerosis (RRMS), while about 35% have SPMS and the remaining 15% have primary progressive MS (PPMS).
Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. It is hypothesized that nasal Foralumab will slow disability accumulation and microglial activation measured by PET imaging in non-active SPMS.
Patients will be dosed in 3-week cycles, with Foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". This study will assess the safety of nasal Foralumab given over 6 months to non-active secondary progressive MS patients who have failed currently available treatments including the standard of care therapy, Ocrevus (ocrelizumab).
Study design
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Confirmed diagnosis of MS (according to the 2010 McDonald criteria).
- Age 25-75 years old.
- Clinical diagnosis of non-active SPMS, as defined by the absence of relapses for 2 years.
- MRI imaging consistent with a diagnosis of MS at any time point.
- Score on the Expanded Disability Status Scale (EDSS) of 2.5-7.5.
Key exclusion criteria (23 listed)
- Need for corticosteroid treatment (oral or intravenous) within the past 30 days or anticipated need within 30 days of foralumab therapy initiation.
- Treatment with Ocrevus® (ocrelizumab), Rituxun® (rituximab), Kesimpta® (ofatumumab), Truxima® (rituximab-abbs) within the past 90 days.
- Treatment with Lemtrada® (alemtuzumab) and Mavenclad® (cladribine) within the past 1 year.
- Treatment with chronic immunosuppressives such as interferon, glatiramer acetate, fingolimod, siponimod, dimethyl fumarate or natalizumab within the past 90 days.
- Inability to tolerate nasally administered medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foralumab TZLS-401 50 µgForalumab 50 µg/dosing day for patients who have failed current therapies. Patients will be dosed in 3-week cycles, with foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". Patients will receive Day 1 doses of nasal foralumab under supervision at the Center for Clinical Investigation at BWH. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foralumab TZLS-401 50 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 16 inclusion and 23 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: status not confirmed, 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.
Are results available for this study?
Results are not available in the source record.
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.
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.