Foralumab for Multiple Sclerosis

Recruiting at 6 trial locations

Overseen By Keeren Shah

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

Trial Summary

What is the purpose of 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.

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+