Foralumab for Multiple Sclerosis

Recruiting at 6 trial locations

Overseen By Pavan Bhargava

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

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental nasal spray treatment called foralumab for individuals with secondary progressive multiple sclerosis (SPMS), a type of MS that gradually worsens over time. The goal is to determine the spray's safety and its effectiveness in reducing brain inflammation compared to a placebo. Participants will receive varying doses of the spray or a placebo to evaluate its effects. Those with a confirmed diagnosis of non-active SPMS for at least two years, who continue to show progression despite previous treatments, might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes participants who have used specific immunosuppressive or immunomodulatory medications within 30 days before screening, and you cannot take these during the study. Additionally, corticosteroids must not have been used within the last 60 days.

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

Research has shown that nasal foralumab is generally safe. In one study with healthy volunteers, oral doses of foralumab up to 5 mg did not raise any safety concerns. More importantly, another study involving patients with non-active secondary progressive multiple sclerosis found that nasal doses of foralumab were well tolerated, with most participants experiencing no serious side effects. These findings provide some confidence in the safety of nasal foralumab, but further research is necessary to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple sclerosis, which often include injectable medications or oral pills like interferons and dimethyl fumarate, Foralumab offers a novel approach with its nasal delivery method. Researchers are excited about Foralumab because it is administered nasally, providing a potentially more convenient and less invasive option compared to traditional methods. This unique delivery targets the immune system in a new way, potentially reducing inflammation with fewer systemic side effects. Additionally, Foralumab is an anti-CD3 monoclonal antibody, which works differently by modulating immune responses, offering hope for improved management of the disease.

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

Research suggests that nasal foralumab could help people with multiple sclerosis (MS). Studies have shown that it reduces brain inflammation, which is linked to MS. Foralumab also appears to stabilize the condition and boost helpful immune responses. Early findings indicate that it might slow MS progression and ease symptoms. In this trial, participants will receive either nasal foralumab at doses of 50 μg or 100 μg, or a nasal placebo. Overall, these results are promising for foralumab as a treatment for MS. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with non-active secondary progressive multiple sclerosis (SPMS). Participants should not be experiencing current flare-ups of their condition. The study is looking for individuals who can undergo PET scans and are willing to receive nasal treatments.

Inclusion Criteria

Screening clinical laboratory studies are within normal ranges or within specified parameters

Confirmed diagnosis of MS according to the 2017 McDonald criteria

MRI imaging consistent with a diagnosis of MS at any time point

Exclusion Criteria

Positivity for HIV, HBsAg, HCV, or tuberculosis

I have recently been treated for an infection.

I don't plan to change my MS medications during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive nasal foralumab or placebo for 3 months, consisting of 4 cycles of 3 weeks each (2 weeks of treatment followed by 1 week of rest)

12 weeks

4 visits (in-person) at the start of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Foralumab

Trial Overview

The study tests the safety and effects of a new treatment, Foralumab, given as a nasal spray at two different doses compared to a placebo. It aims to see if Foralumab can reduce brain inflammation in SPMS over three months, measured by special brain scans called PET.

How Is the Trial Designed?

Group I: Nasal Foralumab 50 μg Experimental Treatment 1 Intervention

Each patient will receive nasal foralumab 50 μg per dosing day (25 μg per nostril).

Group II: Nasal Foralumab 100 μg Experimental Treatment 1 Intervention

Each patient will receive nasal foralumab 100 μg per dosing day (50 μg per nostril).

Group III: Nasal placebo (acetate buffer) Placebo Group 1 Intervention

Each patient will receive placebo on each dosing day in divided doses, in each nostril.

Who Is Running the Clinical Trial?

Tiziana Life Sciences LTD

Lead Sponsor

Trials

13

Recruited

310+

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06292923

NCT06292923 | A Study of Nasal Foralumab in Non-Active ...

Nasal anti-CD3 monoclonal antibody (Foralumab) reduces PET microglial activation and blood inflammatory biomarkers in two patients with non-active secondary ...

4.

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 ...

4. Tiziana Life Sciences Announces Comprehensive Positive Results from Study of Nasal Foralumab in Patients with Multiple Sclerosis. News ...

5.

tizianalifesciences.com

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

Intranasal Foralumab

The treatment demonstrated a reduction in lung inflammation and blood inflammatory biomarkers, with improved lung CT scan results compared to the control group.

6.

tizianalifesciences.com

tizianalifesciences.com/drug-pipeline/intranasal-foralumab/secondary-progressive-multiple-sclerosis-2/

Secondary Progressive Multiple Sclerosis

18 subjects received Foralumab treatment, and 9 patients received placebo. All nasal doses were well tolerated. Biomarker analysis showed significant positive ...

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 ...