Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
← catalyst calendarNCT05909761 · readout in 2,264 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
60estimated
Sites
1
Country
United States
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 | 2026-04-15 | estimated | When the study began enrolling |
| Primary completion | 2032-10-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-06-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Neuromyelitis Optica Spectrum Disorder
- Pregnancy Related
Intervention
- Drug: UPLIZNA — also filed as inebilizumab-cdon
Primary outcomes
what the primary-completion date above is the date OFNumber of newborns with Major Congenital Malformations (MCMs)
measured Minimum of 10 years
Number of newborns with Preterm birth
measured Minimum of 10 years
Number of newborns with low birth weight
measured Minimum of 10 years
Number of stillbirths
measured Minimum of 10 years
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