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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909761
• Other study ID #: VIB0551.P4.S4
• Secondary ID: EUPAS105613
• Status: Recruiting
• Start date: July 17, 2023
• Est. completion date: August 2032

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Acquired from Horizon in 2024.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2032
• Est. primary completion date: August 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder
• Pregnancy Related

Intervention

Drug:
• UPLIZNA
Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of newborns with Major Congenital Malformations (MCMs)		Minimum of 10 years
Primary	Number of newborns with Preterm birth		Minimum of 10 years
Primary	Number of newborns with low birth weight		Minimum of 10 years
Primary	Number of stillbirths		Minimum of 10 years
Secondary	Number of newborns with Minor Congenital Malformations		Minimum of 10 years
Secondary	Number of infants with developmental milestone abnormalities		Minimum of 10 years
Secondary	Number of infants with neurologic abnormalities		Minimum of 10 years
Secondary	Number of infants with immune system development abnormalities		Minimum of 10 years
Secondary	Number of Spontaneous Abortions		Minimum of 10 years
Secondary	Number of Induced or Elective Abortions		Minimum of 10 years