clinical trial · NCT05909761
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Amgen·—·recruiting·n = 60
Neuromyelitis Optica Spectrum DisorderPregnancy RelatedUPLIZNA
brief summary
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.
started
Apr 15, 2026
primary completion
Oct 31, 2032
completion
Oct 31, 2032
last updated
Jan 27, 2026
detailed description
Acquired from Horizon in 2024.
official title
An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol