Nasal Foralumab for Multiple Sclerosis

(TILS-022 Trial)

Overseen By William Clementi, PharmD FCP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tiziana Life Sciences LTD

Must not be taking: Corticosteroids, Immunosuppressants, B cell depleters

Disqualifiers: Pregnancy, Malignancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests nasal foralumab, a medicine delivered through the nose, to determine its effectiveness for individuals with non-active secondary progressive multiple sclerosis. This type of multiple sclerosis (MS) progresses over time without new relapses. Participants will begin with a specific dose, which may increase based on their health status. Only those who completed a previous related trial can join, and the study aims to provide up to six months of treatment. Suitable candidates must have finished the prior trial without major issues and should not use certain medications or have health conditions that might interfere with the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important MS research.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, especially those that affect the immune system, like corticosteroids and other immunosuppressive drugs, at least 30 to 60 days before starting the study. If you're on any of these medications, you'll need to stop them before participating.

Is there any evidence suggesting that nasal foralumab is likely to be safe for humans?

Research has shown that nasal Foralumab is generally safe for people. In one study with healthy volunteers, participants tolerated a 50 microgram dose well, experiencing no serious side effects. Another study with multiple sclerosis patients also demonstrated good safety results. Specifically, it found that Foralumab lowered certain immune responses related to the disease without causing harm. Overall, current research suggests the treatment is safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Nasal foralumab is unique because it offers a new way to treat multiple sclerosis by using an anti-inflammatory antibody delivered directly through the nose. Unlike the standard treatments that often involve injections or oral medications targeting the immune system broadly, nasal foralumab specifically aims to reduce inflammation in the brain via the nasal passage, which may lead to fewer side effects. Researchers are excited about this approach because it could provide a more targeted treatment with potentially faster and more specific benefits for patients.

What evidence suggests that nasal foralumab might be an effective treatment for multiple sclerosis?

Research has shown that nasal foralumab, which participants in this trial will receive, might help treat multiple sclerosis (MS). Studies have found that it can slow the progression of MS and help manage its symptoms. In trials, patients using nasal foralumab experienced stabilization of their condition, meaning it did not worsen. The treatment also reduced the activity of certain brain cells involved in inflammation. Additionally, nasal foralumab has helped alleviate fatigue in patients. Overall, these findings suggest that nasal foralumab could be a promising option for people with MS. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients who have completed the TILS-021 study for non-active secondary progressive multiple sclerosis. Participants will receive nasal Foralumab, initially at a lower dose which may be increased based on their clinical status.

Inclusion Criteria

My vaccinations are current, considering my health and treatments.

Adequate hematologic parameters without ongoing transfusion support: Hemoglobin (Hb) ≥ 9 g/dL, Platelets ≥ 100 x 10^9 cells/L

Subjects must have enrolled in and successfully completed TILS-021 within the preceding 90 days, including End of Treatment and End of Study assessments

Exclusion Criteria

Subjects that terminated TILS-021 early as defined by not undergoing End of Study visit

I have had a stem cell transplant using my own cells.

I have not taken certain medications in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nasal foralumab 50 µg three days a week for two weeks, followed by a one-week rest, in 3-week cycles. Dose may be escalated to 100 µg at week 12.

24 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term, pending FDA approval

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Foralumab

Trial Overview The trial tests nasal Foralumab in a 6-month open-label extension where all participants start with a low dose that can be escalated. It's designed to give those from a previous placebo-controlled study access to the drug and assess longer-term effects.

How Is the Trial Designed?

Group I: Nasal foralumab 50 μg per dosing day (25 μg per nostril) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Tiziana Life Sciences LTD

Lead Sponsor

Trials

13

Recruited

310+

Published Research Related to This Trial

Ofatumumab is an all-human monoclonal antibody that effectively reduces the frequency of exacerbations and the risk of disability progression in patients with multiple sclerosis, showing better results compared to teriflunomide.

This drug can be used as a second-line therapy for patients with active relapsing MS or secondary progressive MS, especially for those who have not responded to first-line treatments or have a high risk of progressive multifocal leukoencephalopathy (PML).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ofatumumab - a new drug for the treatment of multiple sclerosis]. Boyko, AN., Smirnova, NF., Shchukin, IA., et al.[2021]

In a retrospective study of 50 patients treated with intravenous ofatumumab for multiple sclerosis and related disorders over a median duration of 2.2 years, the annualized relapse rate significantly decreased from 1.03 to 0.38, indicating effective disease control.

While ofatumumab treatment showed a stabilization of disability worsening (7% at 24 months), there was a high incidence of infusion-related reactions (86% during the first infusion), suggesting a need for careful monitoring during administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous ofatumumab treatment of multiple sclerosis and related disorders: An observational study. El Mahdaoui, S., Romme Christensen, J., Magyari, M., et al.[2022]

In phase 3 trials, patients with relapsing-remitting multiple sclerosis treated with alemtuzumab showed significant improvements in quality of life (QoL) across multiple measures, including physical, mental, and emotional aspects, sustained through Year 2.

Alemtuzumab demonstrated greater QoL improvements compared to subcutaneous interferon beta-1a at all time points, indicating its superior efficacy in enhancing the overall well-being of patients, regardless of their treatment history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alemtuzumab improves quality-of-life outcomes compared with subcutaneous interferon beta-1a in patients with active relapsing-remitting multiple sclerosis. Arroyo González, R., Kita, M., Crayton, H., et al.[2018]

Citations

1. tizianalifesciences.com tizianalifesciences.com/tiziana-life-sciences-announces-comprehensive-positive-results-from-study-of-nasal-foralumab-in-patients-with-multiple-sclerosis/

Tiziana Life Sciences Announces Comprehensive Positive ... This comprehensive study demonstrated that nasal foralumab was safe, induced potent regulatory immune responses, reduced microglial activation, and stabilized ...

2. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/articles/foralumab

Foralumab Nasal Spray May Offer New Hope for MS ... A nasal spray called foralumab may help slow multiple sclerosis progression and help MS patients manage symptoms. Learn how this research ...

3. neurologylive.com neurologylive.com/view/phase-2a-inform-ms-trial-study-anti-cd3-agent-foralumab-non-active-secondary-progressive-ms

Phase 2a INFORM-MS Trial to Study Anti-CD3 Agent ... In May, preliminary data from 10 patients in the trial showed that all treated participants had stabilization of their Expanded Disability ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06292923

NCT06292923 | A Study of Nasal Foralumab in Non-Active ... Treatment of six non-active secondary progressive MS patients with nasal anti-CD3 monoclonal antibody (Foralumab): safety, biomarker, and disability outcomes.

5. medrxiv.org medrxiv.org/content/10.1101/2025.04.30.25326602v1.full-text

Nasal foralumab treatment of PIRA induces regulatory ... In summary, nasal foralumab in treatment-refractory non-active SPMS patients showed stabilization in EDSS, improvement in fatigue scores and ...

6. tizianalifesciences.com tizianalifesciences.com/drug-pipeline/intranasal-foralumab/

Intranasal Foralumab A Phase 1 trial in healthy volunteers showed that nasal Foralumab was well-tolerated and modulated immune biomarkers, notably at the 50 µg dose. ​. Recent ...

7. trialx.com trialx.com/clinical-trials/listings/298941/nasal-foralumab-in-patients-with-non-active-secondary-progressive-multiple-sclerosis/

Nasal Foralumab in Patients With Non-Active Secondary ... It will assess the safety and potential efficacy as reflected in microglial activation on the PET scan, neurologic exam and measures, and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06489548

Study Details | NCT06489548 | Assessment of Foralumab ... Nasal Foralumab has been given to healthy volunteers with progressive multiple sclerosis (MS). When given nasally for five consecutive days, doeses up to ...