Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT05909761
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2023-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT06590051
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EUPAS105613 | OTHER | European Union Post Authorization Studies | View |