NCT05909761Recruiting

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

Amgen

Start Date

4/15/2026

Completion Date

10/31/2032

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.

Detailed Description

Acquired from Horizon in 2024.

Eligibility Criteria

Age Range: 15 years to No maximum

Inclusion Criteria: * 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

Interventions

DRUG

UPLIZNA

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Conditions

Neuromyelitis Optica Spectrum DisorderPregnancy Related

Locations

University of Colorado Denver

Aurora, Colorado 80045

United States