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Inebilizumab · 1 trial · 1 indication
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.
| Arm | Type | Description |
|---|---|---|
| Placebo/Inebilizumab | PLACEBO_COMPARATOR | Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug. |
| Inebilizumab/Inebilizumab | EXPERIMENTAL | AQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug. |
| Name | Type | Description |
|---|---|---|
| Inebilizumab | DRUG | Participants will receive IV inebilizumab 300 mg. |
| Placebo | OTHER | Participants will receive IV placebo matched to inebilizumab. |
Inclusion Criteria: 1. Men and women 18 years or older with diagnosis of NMO/NMOSD 2. Confirmation of NMO/NMOSD status: 1. AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years 2. AQP4-I...
Inebilizumab is an investigational drug being studied for the treatment of Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders, which are rare autoimmune conditions affecting the central nervous system. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Inebilizumab targets CD19, a protein expressed on B cells, and works by depleting these cells to reduce the autoimmune attack in Neuromyelitis Optica Spectrum Disorders. This mechanism is intended to modulate the immune response and potentially reduce disease activity.
Inebilizumab is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Neuromyelitis Optica Spectrum Disorders.
Inebilizumab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to determine its safety and effectiveness for treating Neuromyelitis Optica Spectrum Disorders.
Inebilizumab has been studied in the N-MOmentum trial (NCT02200770), a Phase 2, randomized, double-blind, placebo-controlled study that enrolled 231 participants with Neuromyelitis Optica Spectrum Disorders. The trial has been completed and included participants from multiple countries across the Americas, Europe, Asia, and other regions.
Inebilizumab is also known as MEDI-551, a name used during its earlier development. Both names refer to the same investigational drug being developed by AstraZeneca for the treatment of Neuromyelitis Optica Spectrum Disorders.