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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
University of Colorado Denver
RECRUITING
Aurora
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2032-10-31
Participants
Target number of participants: 60
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov