Phase 4 Multiple Sclerosis Trial, By Invitation

MS-related:

• People who have been diagnosed with secondary progressive MS and have had no relapses for at least 1 year.
• People who have been diagnosed with primary progressive MS.
• People who have previously taken any disease-modifying therapy for MS.
• People who have previously received, or are currently receiving, any experimental treatment or participated in another clinical trial for MS (for example, treatment for chronic cerebrospinal venous insufficiency).

Infection-related:

• People with a known history of recurring or ongoing infections such as HIV, syphilis, or tuberculosis.
• People with a history of recurring aspiration pneumonia that required antibiotic treatment.
• People with a history or known presence of infections that can affect the spinal cord, such as syphilis, Lyme disease, HTLV-1, or herpes zoster myelopathy.
• People with a known active infection of any kind — bacterial, viral, fungal, or other — or who have been hospitalised for an infection or treated with intravenous antibiotics within the 4 weeks before the baseline visit, or oral antibiotics within the 2 weeks before the baseline visit.

Cancer-related:

• People with a history of cancer, including solid tumours and blood cancers, except for certain skin cancers or cervical/uterine carcinoma that have been fully removed and confirmed clear on pathology testing.

Women's health-related:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• Women who could become pregnant and do not have a negative pregnancy test result (blood or urine) within 14 days before starting the study treatment.

Other medical conditions:

• People who are on blood-thinning medication or have a known blood-clotting disorder.
• People with a current or past history of a primary or secondary immune system deficiency.
• People who have had a severe allergic or anaphylactic reaction to humanised or murine monoclonal antibody treatments.
• People with a history of alcohol or other substance misuse within 24 weeks before joining the study.
• People with a known or past history of a systemic autoimmune condition that could cause progressive neurological disease, such as lupus, anti-phospholipid antibody syndrome, Sjögren's syndrome, or Behçet's disease.
• People who have any condition that may require ongoing treatment with systemic steroids or immune-suppressing medications during the study.
• People with significant, uncontrolled disease in areas such as the heart (including moderate to severe heart failure or irregular heart rhythm), uncontrolled high blood pressure, lungs, kidneys, liver, hormonal system (including uncontrolled diabetes), or digestive system.
• People with a known or past history of other neurological disorders.
• People who have received systemic corticosteroid (steroid) therapy within 4 weeks before the baseline visit.
• People who cannot tolerate or have contraindications to oral or intravenous corticosteroids, including intravenous methylprednisolone, or who are allergic to any component of these treatments.
• People who have previously been treated with certain powerful immune-suppressing or chemotherapy agents, including cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate, or who have undergone total body irradiation or bone marrow transplantation.

Laboratory results:

• People with a positive pregnancy hormone (β-hCG) result in blood or urine.
• People who test positive for hepatitis B (confirmed by specific blood tests).
• People whose liver enzyme levels (AST or ALT) are more than twice the upper limit of the normal range.
• People whose platelet count is below the normal range.
• People whose total white blood cell count, including the breakdown of cell types, is below the normal range.
• People whose neutrophil count (a type of white blood cell) is below the normal range.
• People whose lymphocyte count (another type of white blood cell) is below the normal range.
• People whose blood immunoglobulin G (IgG) levels are more than 18% below the lower limit of normal, or whose immunoglobulin M (IgM) levels are more than 8% below the lower limit of normal.
• People whose CD4+ and CD8+ immune cell counts and CD4:CD8 ratio fall outside the normal range (confirm with trial site).