Expanded Access Study of Nasal Foralumab for Patients with Non-Active Secondary Progressive Multiple Sclerosis (SPMS)

Sponsor: Tiziana Life Sciences LTD

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06802328

Provider View

This study offers access to a treatment called Foralumab for patients with non-active secondary progressive multiple sclerosis (SPMS) who have not responded to other therapies. The treatment is given as a nasal spray, and the study aims to evaluate its safety and effects on the immune system.

Patient Parameters

Program Overview

The study is designed to provide Foralumab, a nasal spray treatment, to patients with non-active secondary progressive multiple sclerosis (SPMS) who have not had success with other treatments. The main goal is to see if Foralumab is safe and how it affects the immune system. Patients will take the medication at home three times a week for three weeks, followed by a week off, and will visit the clinic every three weeks for check-ups.

Description

Multiple sclerosis (MS) is a condition where the immune system mistakenly attacks the central nervous system. Foralumab is a treatment being tested to help slow down the progression of disability in people with non-active secondary progressive MS (SPMS). This study will provide Foralumab as a nasal spray to patients who have not responded to other treatments, including Ocrevus. The treatment is given in cycles: patients will use the nasal spray on Days 1, 3, and 5 of the first two weeks, followed by a week off. The study will last for six months, during which the safety of Foralumab will be closely monitored.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with multiple sclerosis (MS) based on specific medical criteria.
  • Aged between 25 and 75 years.
  • Have non-active secondary progressive MS, meaning no relapses in the past two years.
  • MRI scans consistent with MS diagnosis.
  • Score between 2.5 and 7.5 on a disability scale.
  • Have not responded to standard treatments and have shown clinical decline for at least six months.
  • Meet specific blood test requirements for hemoglobin and platelets.
  • Have normal kidney and liver function based on blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 90 days after.
  • Up-to-date immunizations as assessed by a doctor.
  • Able to provide written consent to participate.

Exclusion Criteria

  • Need for steroid treatment within the past 30 days or expected need soon.
  • Recent treatment with certain MS medications like Ocrevus, Rituxan, or Lemtrada.
  • Cannot tolerate nasal medications.
  • Recent nasal issues like chronic rhinitis or sinusitis.
  • Active COVID-19 or recent vaccination.
  • Pregnant or breastfeeding women, or those planning to become pregnant.
  • History of certain autoimmune diseases or active cancer within the past five years.
  • Severe immune system issues or recent serious infections.
  • Heart problems or medications that affect heart rhythm.
  • Positive tests for HIV, hepatitis B, or hepatitis C.
  • Any condition that might interfere with the study or its results.

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