← Back to Search

Monoclonal Antibodies

Nasal Foralumab 100 μg for Multiple Sclerosis

Phase 2

Recruiting

Research Sponsored by Tiziana Life Sciences LTD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study, an average of 12 weeks (3 months).

Awards & highlights

Study Summary

This trial is testing a new drug called foralumab, which is an antibody that targets specific immune cells, for the treatment of multiple sclerosis. The study will evaluate the safety and effectiveness of two

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

As an anti-CD3 monoclonal antibody, Foralumab may cause side effects related to immune system reactions such as headaches, fever or chills. Nasal administration could lead to irritation or discomfort in the nose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study, an average of 12 weeks (3 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study, an average of 12 weeks (3 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, an average of 12 weeks (3 months). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline for [18F]PBR06-positron emission tomography (PET) scans for microglial activation after 12 weeks (3 months) of study treatment.

Changes in the Total Nasal Symptom Score (TNSS).

The number of patients with adverse event (AE) reports.

Secondary outcome measures

Changes in the Expanded Disability Status Scale (EDSS).

Changes in the Modified Fatigue Impact Scale (MFIS).

Changes in the Multiple Sclerosis Functional Composite-4 (MSFC-4).

Other outcome measures

Changes in percent brain volume change by 3T MRI analysis pipeline between the Screening Visit (Baseline) and after 3 months of treatment, as measured by 3T MRI.

Changes in the mean number of gadolinium-enhancing lesions per T1-weighted MRI scan, as measured by 3T MRI.

Paramagnetic rim lesions by quantitative susceptibility mapping sequences on MRI, as measured by 3T MRI (if center is able).

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Nasal Foralumab 50 μgExperimental Treatment1 Intervention

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

Group II: Nasal Foralumab 100 μgExperimental Treatment1 Intervention

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

Group III: Nasal placebo (acetate buffer)Placebo Group1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tiziana Life Sciences LTDLead Sponsor

8 Previous Clinical Trials

161 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 45 eligible to participate in this trial?

"Individuals aged 18 and above, up to a maximum age of 75, are eligible for enrollment in this study according to the specified eligibility criteria."

Answered by AI

What are the eligibility criteria for individuals seeking to participate in this clinical study?

"Individuals aged between 18 and 75 years diagnosed with multiple sclerosis are sought to fill the 54 slots available in this clinical trial."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"As per the details provided on clinicaltrials.gov, this investigation is actively seeking participants. It was first listed on 11/15/2023 and last modified on 2/27/2024."

Answered by AI

How large is the participant pool in this medical study?

"Indeed, the information on clinicaltrials.gov affirms that this research is actively seeking subjects. Initially shared on November 15th, 2023, and most recently revised on February 27th, 2024. The trial aims to recruit a total of 54 patients from one designated site."

Answered by AI

Has the FDA granted approval for Nasal Foralumab 100 μg?

"According to our evaluation at Power, Nasal Foralumab 100 μg has been rated a 2 on the safety scale. This assessment is based on it being a Phase 2 trial with existing safety data but lacking efficacy evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

2023. "A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06292923.

All > Paid Studies Boston