臨床研究等提出・公開システム

Scientific Title	An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects with Systemic Sclerosis
Public Title	An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects with Systemic Sclerosis

Contact for Scientific Queries	Name	Nishiura Tomoyuki
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-753253279
	E-mail	ctinfo@mii.maruho.co.jp
Contact for Public Queries	Name	Information Trials Clinical
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-753253279
	E-mail	ctinfo@mii.maruho.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 12, 2021
Actual date of first enrollment		April. 20, 2022
Target sample size		8
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	-Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria -Systemic Sclerosis patients with moderate to sever skin sclerosis
	Exclusion Criteria	-Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease -Patients with a diseases that could interfere with assessment of Systemic Scleorosis -Patients with body weight less than 30.0kg -Pregnant or lactating women.
	Age Minimum	20age old over
	Age Maximum	70age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Systemic Sclerosis
Intervention(s)		Nemolizumab will be administered subcutaneously
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24
Secondary Outcome(s)

Primary Sponsor	Maruho Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	the Institutional Review Board, the University of Tokyo Hospital
Address	7-3-1, Hongo Bunkyo-ku, Tokyo, Tokyo
Telephone	+81-3-5800-8743
E-Mail	IRBjimu-tokyo@umin.ac.jp
Approval Status	Approval
Date of approval	Dec. 21, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history