臨床研究等提出・公開システム

Date of registration	May. 07, 2021
Last modified on	May. 07, 2021
Trial ID	jRCT2051210017

Scientific Title	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
Public Title	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

Contact for Scientific Queries	Name	Sato Toshiyuki
	Affiliation	PPDSNBL K.K
	Address	St Luke's Tover 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6821-0900
	E-mail	Toshiyuki.Sato@ppd.com
Contact for Public Queries	Name	Sato Toshiyuki
	Affiliation	PPDSNBL K.K
	Address	St Luke's Tover 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6821-0900
	E-mail	Toshiyuki.Sato@ppd.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		May. 07, 2021
Actual date of first enrollment		Oct. 15, 2020
Target sample size		7
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
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.
Primary Outcome(s)		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.

Primary Sponsor	Viela Bio, Inc.

Name of Certified Review Board	Kyoto Min-iren Chuo Hospital Institutional Review Board
Address	2-1 Uzumasa Tsuchimoto-cho, Ukyo-ku, Kyoto-shi, Kyoto
Telephone	+81-75-861-2220
E-Mail	nishida_tokiko@kyoto-hokenkai.jp
Approval Status	Approval
Date of approval	Nov. 02, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none