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An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab

An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2051210017
Enrollment
7
Registered
2021-05-07
Start date
2020-10-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Interventions

This study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300

Sponsors

Sato Toshiyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Has completed at least 2 years in the OLP of Study CD-IA-MEDI-551-1155, and has not discontinued inebilizumab treatment in that study Is deemed eligible to continue receiving inebilizumab by the Investigator

Exclusion criteria

Exclusion criteria: Has any condition that, in the opinion of the Investigator, would place the patient at unacceptable risk of complications, interfere with evaluation of inebilizumab or confound the interpretation of patient safety or study results Lactating or pregnant females, or females who intend to become pregnant after signing the informed consent

Design outcomes

Primary

MeasureTime frame
To provide continuation of inebilizumab treatment to patients who completed the OLP of Study CD-IA-MEDI-551-1155, and to characterize the effects of long term inebilizumab treatment on safety, laboratory, and other measures; and to monitor recovery of particular laboratory measures following discontinuation of inebilizumab.

Contacts

Public ContactToshiyuki Sato

PPDSNBL K.K

Toshiyuki.Sato@ppd.com+81-3-6821-0900

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026