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

Recruiting

• Conditions: Neuromyelitis Optica Spectrum Disorder; Pregnancy Related

• Registration Number: NCT05909761
• Lead Sponsor: Amgen

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Study Start: 2025-04-14
• Primary Completion: 2032-10-31
• Study Completion: 2032-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of newborns with Major Congenital Malformations (MCMs)	Minimum of 10 years
Number of stillbirths	Minimum of 10 years
Number of newborns with Preterm birth	Minimum of 10 years
Number of newborns with low birth weight	Minimum of 10 years

Secondary Outcome Measures

Name	Time	Method
Number of newborns with Minor Congenital Malformations	Minimum of 10 years
Number of infants with developmental milestone abnormalities	Minimum of 10 years
Number of infants with neurologic abnormalities	Minimum of 10 years
Number of Induced or Elective Abortions	Minimum of 10 years
Number of Spontaneous Abortions	Minimum of 10 years
Number of infants with immune system development abnormalities	Minimum of 10 years

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States