Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy

Recruiting now

Conditions studied: Neuromyelitis Optica Spectrum Disorder, Pregnancy Related

In brief

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.

Key facts

Study ID

NCT05909761

Run by

Amgen

People needed

60

Starts

2026-04-15

Expected to finish

2032-10-31

Last updated by the study team

2026-01-27

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Provide informed consent
• Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
• Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception
• Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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