Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT02200770) looked at a condition called Neuromyelitis Optica Spectrum Disorder (NMOSD), a rare disease that can cause episodes of worsening symptoms affecting vision, movement, and other functions. A total of 231 people took part in the main controlled phase — 56 received a placebo (an inactive treatment) followed later by the study drug inebilizumab, while 175 received inebilizumab from the start. The trial was primarily measuring how long it took before participants experienced a confirmed NMOSD attack, and also tracked a range of other things including changes in disability, vision, brain and spinal cord scans, and hospital stays. The reported data shows that for the primary measure — time to a confirmed NMOSD attack — no specific number of days was reported in the submitted data for either group. For the secondary measures, the percentage of people whose disability score worsened during the controlled phase was reported as 33.9% in the placebo group and 14.9% in the inebilizumab group. A vision test using both eyes showed an average score of 1.44 (placebo) versus 1.58 (inebilizumab) out of a possible 70, where a higher score means better vision. The average number of new or active lesions spotted on brain and spinal cord scans was 2.3 in the placebo group and 1.6 in the inebilizumab group. The number of NMOSD-related hospital stays was 1.4 in the placebo group and 1.0 in the inebilizumab group. The reported data also shows that across all participants who received inebilizumab at any point in the trial (including both phases), the average number of confirmed NMOSD attacks per year was reported as 0.086 — meaning roughly 86 attacks for every 1,000 people over one year. These figures are simply what was recorded and counted during the trial period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 39222408) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Transverse Myelitis Trial, Completed
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:
- You are a man or woman aged 18 or older who has been diagnosed with NMO or NMOSD (a rare disease affecting the spinal cord and optic nerves)
- Your NMO/NMOSD has been confirmed by blood tests (either positive or negative for a protein called AQP4-IgG), and you have had at least one serious attack needing emergency treatment in the past year, or at least two such attacks in the past two years
- You are willing and able to sign a consent form and follow the rules of the study
- Your level of physical disability falls within a certain range on a standard medical scale (confirm with trial site)
- If you are able to have children, you must agree to use a highly effective form of contraception from the start of the trial until 6 months after your last dose of the study treatment
Who may not be able to join:
- You are pregnant or currently breastfeeding
- You have taken part in another clinical trial or received an experimental treatment within the past 4 weeks
- You have a known history of a severe allergic reaction to any ingredient in the study treatment, or have ever had a severe allergic reaction to a biologic medicine
- You currently have a serious active infection (bacterial, viral, or other) or have recently been hospitalised because of an infection
- You have a history of alcohol, drug, or chemical misuse within the past year
- You have ever received certain powerful immune-system treatments, including alemtuzumab, total lymphoid irradiation (a type of radiation therapy), a bone marrow transplant, or T-cell vaccination therapy
- You received a treatment called rituximab or a similar B-cell depleting drug within the past 6 months and your B-cell levels (a type of immune cell) are below the normal range
- You received intravenous immunoglobulin (IVIG) within the past month
- You have received any of the following medications in the past 3 months: natalizumab, cyclosporin, methotrexate, mitoxantrone, cyclophosphamide, tocilizumab, or eculizumab
- You have a history of Hepatitis B or Hepatitis C
- You have a known condition that weakens the immune system, such as HIV
- You have a history of cancer, other than certain treated skin cancers that were successfully cured more than 3 months ago
- You have another condition (besides NMO/NMOSD) that has required high-dose steroid treatment for an extended period of time
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: MedImmune, LLC MedImmune, LLC, MedImmune LLC
Australian sites
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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
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.