Phase 2 Transverse Myelitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children and teenagers between 2 and under 18 years old, who weigh at least 15 kg (about 33 lbs), regardless of sex.
- Participants who have tested positive for a specific antibody called anti-AQP4-IgG in their blood and have been diagnosed with a condition called NMOSD (Neuromyelitis Optica Spectrum Disorder).
- Participants who have had at least one NMOSD attack (relapse) in the past year, or at least two NMOSD attacks in the past two years.
Who may not be able to join:
- Anyone with a health condition that, in the doctor's opinion, could interfere with the study or affect the safety results (confirm with trial site).
- Anyone who has taken part in another clinical trial using an experimental treatment within the past 4 weeks or longer, depending on the treatment used.
- Anyone with significant problems with their liver, kidneys, metabolism, or blood counts (confirm with trial site).
- Anyone whose B-cell count (a type of immune cell) is too low for their age based on lab testing.
- Anyone who has ever received any of the following treatments at any time: alemtuzumab, total lymphoid irradiation (a type of radiation therapy), a bone marrow transplant, or T-cell vaccination therapy.
- Anyone who received rituximab or a similar experimental immune-cell-reducing treatment within the past 6 months, unless their B-cell counts have recovered to an acceptable level.
- Anyone who received intravenous immunoglobulin (IVIG, a blood-derived immune treatment) within the past month.
- Anyone who received any of the following medications within the past 2 months: cyclosporine, methotrexate, mitoxantrone, cyclophosphamide, tocilizumab, satralizumab, or eculizumab.
- Anyone who received natalizumab (Tysabri®) within the past 6 months.
- Anyone with a history of severe allergic reactions or anaphylaxis to 2 or more foods or medicines, including known sensitivity to paracetamol/acetaminophen, antihistamines, or steroid medications like methylprednisolone.
- Anyone with another autoimmune disease that is not well controlled (unless the medical team overseeing the study approves).
- Anyone who received a live or weakened (attenuated) vaccine within the past 4 weeks (note: certain non-live vaccines are acceptable — confirm with trial site).
- Anyone who received the BCG (tuberculosis) vaccine within the past year.
- Anyone who had a blood transfusion within the past 4 weeks before or during the screening period.
- Anyone with a serious active or long-lasting infection (viral, bacterial, or fungal) that has required treatment or hospitalisation within the past 2 months.
- Anyone with a known history of a weakened immune system due to conditions such as HIV, removal of the spleen, or other immune deficiencies that increase infection risk.
- Anyone who tests positive for a chronic hepatitis B infection at screening.
- Anyone who tests positive for hepatitis C antibodies.
- Anyone who tests negative for immunity to chickenpox (varicella zoster virus).
- Anyone with a history of cancer, except for certain treated skin cancers that were successfully cured more than 3 months ago.
- Anyone with a history of active or latent (inactive) tuberculosis, or a positive TB screening test, unless they have completed TB treatment or are actively on treatment and have completed at least one month of it (confirm with trial site for specific rules).
- Anyone who is unable to have an MRI scan, for example due to an allergy to MRI contrast dye, or having a pacemaker or other metal implants in or on the body.
- Anyone who is unable to tolerate or cooperate with the MRI scanning procedure.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: MD, Amgen
Phone: 866-572-6436
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Maximum Observed Concentration (Cmax) of Inebilizumab; Area Under the Concentration Versus Time Curve of Inebilizumab from Time 0 to 14 Days Post-dose (AUC0-14d); Area Under the Concentration Versus Time Curve of Inebilizumab from Time 0 Extrapolated to Infinity (AUC0-Inf); Systemic Clearance (CL) of Inebilizumab; Terminal Elimination Half-life (t½) of Inebilizumab; Volume of Distribution at Steady State (VSS) of Inebilizumab; Change from Baseline in Peripheral Cluster of Differentiation (CD)20-positive B-cell Counts; Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.