An Observational Pregnancy Safety Study in Women with Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (inebilizumab-cdon) during Pregnancy (VIB0551.P4.S4 /20230064)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105845
• EU PAS number:
  EUPAS105613
• Study ID:
  105845
• Official title and acronym:
  An Observational Pregnancy Safety Study in Women with Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (inebilizumab-cdon) during Pregnancy (VIB0551.P4.S4 /20230064)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Denmark

  Finland

  France

  Germany

  Norway

  Sweden

  United States
• Study description:
  This global observational pregnancy safety study is conducted to better characterize how inebilizumab commercial product (UPLIZNA) may affect pregnancy and infant outcomes. ; The study is a post-marketing commitment that aims to monitor female patients who were exposed to UPLIZNA during pregnancy, as defined by receipt of any dose during pregnancy or within 6 months preceding conception. The primary objectives are: (1) to assess pregnancy and birth outcomes in female patients with neuromyelitis optica spectrum disorder (NMOSD), exposed to inebilizumab commercial product (UPLIZNA) during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception, (2) to describe major congenital malformations, minor congenital malformations, spontaneous abortions, stillbirths, preterm births, and small-for-gestational-age births, if they occur, in women with gestational exposure to UPLIZNA. ; The study period is a minimum 10 years.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 11/11/2022

Study start date

Planned: 01/07/2023

Actual: 10/07/2023

Data analysis start date

Planned: 16/02/2033

Date of interim report, if expected

Planned: 31/07/2026

Date of final study report

Planned: 31/07/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Horizon Therapeutics

Study protocol

Updated protocol

Protocol-Published Original inebilizumab-cdon 20230064 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

VIB0551.P4.S4