Foralumab for Multiple Sclerosis
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.12345
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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Foralumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tiziana Life Sciences LTD
Lead Sponsor