Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
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Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
15estimated
Sites
19
Countries
Argentina, Brazil, Canada +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-03 | actual | When the study began enrolling |
| Primary completion | 2027-04-13 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-04-13 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Neuromyelitis Optica Spectrum Disorder
Intervention
- Drug: Inebilizumab
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Concentration (Cmax) of Inebilizumab
measured Day 1 to Week 28
Area Under the Concentration Versus Time Curve of Inebilizumab from Time 0 to 14 Days Post-dose (AUC0-14d)
measured Day 1 to pre-dose on Day 15
Area Under the Concentration Versus Time Curve of Inebilizumab from Time 0 Extrapolated to Infinity (AUC0-Inf)
measured Day 1 to Week 80
Systemic Clearance (CL) of Inebilizumab
measured Day 1 to Week 80
Terminal Elimination Half-life (t½) of Inebilizumab
measured Day 1 to Week 80
Volume of Distribution at Steady State (VSS) of Inebilizumab
measured Day 1 to Week 80
Change from Baseline in Peripheral Cluster of Differentiation (CD)20-positive B-cell Counts
measured Week 1, Week 2, Week 28, Week 80
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
measured Day 1 to Week 80
Change from Baseline in Serum Chemistry
measured Week 1, Week 2, Week 28, Week 80
Change from Baseline in Hematology
measured Week 1, Week 2, Week 28, Week 80
Change from Baseline in Serum Immunoglobulins
measured Week 1, Week 2, Week 28, Week 80
Change from Baseline in Systolic Blood Pressure
measured Week 1, Week 2, Week 28, Week 80
Change from Baseline in Diastolic Blood Pressure
measured Week 1, Week 2, Week 28, Week 80
Change from Baseline in Pulse Rate
measured Week 1, Week 2, Week 28, Week 80
Change from Baseline in Respiratory Rate
measured Week 1, Week 2, Week 28, Week 80
Change from Baseline in Body Temperature
measured Week 1, Week 2, Week 28, Week 80
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