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

JRCT ID: jRCT2051210017

Registered date:07/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
• Date of first enrollment: 15/10/2020
• Target sample size: 7
• Study type: Interventional
• Intervention(s): 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 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects.

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sato Toshiyuki