Inebilizumab for Neuromyelitis Optica
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before starting, such as rituximab, IVIG, and others listed in the exclusion criteria. If you're on any of these, you may need to stop them for a specific period before joining the trial.
Is inebilizumab safe for humans?
Inebilizumab, also known as Uplizna, has been generally well tolerated in clinical trials for neuromyelitis optica spectrum disorder (NMOSD), with common side effects including urinary tract infections and joint pain. It has been used safely in humans for over four years in studies, with the most frequent side effects being infusion reactions and respiratory infections.12345
How does the drug inebilizumab work for neuromyelitis optica?
Inebilizumab is unique because it targets and depletes B cells that express a specific marker called CD19, which helps reduce attacks in neuromyelitis optica. It is given as an intravenous infusion and has been shown to lower the risk of attacks and hospitalizations in patients with this condition.13467
What is the purpose of this trial?
A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to \< 18 years of age with recently active neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for autoantibodies against aquaporin-4 (AQP4-immunoglobulin \[Ig\]G).
Research Team
MD
Principal Investigator
Amgen
Eligibility Criteria
This trial is for kids aged 2 to <18 with Neuromyelitis Optica Spectrum Disorder (NMOSD) who've had at least one relapse in the past year or two in the last two years. They must test positive for AQP4-IgG antibodies and meet specific diagnostic criteria. Kids can't join if they've recently taken certain meds, received live vaccines or blood transfusions, have uncontrolled autoimmune diseases, significant organ dysfunction, severe allergies to multiple drugs/foods, or low B-cell counts.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Inebilizumab administered intravenously over 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Inebilizumab
Inebilizumab is already approved in United States, European Union, Canada for the following indications:
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Horizon Therapeutics Ireland DAC
Lead Sponsor