臨床研究等提出・公開システム

Japanese

Date of registration	June. 25, 2023
Last modified on	Nov. 21, 2023
Trial ID	jRCT2031230174

Scientific Title	A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Infant and Pediatric Atopic Dermatitis Patients with moderate to severe pruritus
Public Title	A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Infant and Pediatric Atopic Dermatitis Patients with moderate to severe pruritus

Contact for Scientific Queries	Name	Nishiura Tomoyuki
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-75-325-3279
	E-mail	ctinfo@mii.maruho.co.jp
Contact for Public Queries	Name	- Clinical Trials Information
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-75-325-3279
	E-mail	ctinfo@mii.maruho.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 25, 2023
Actual date of first enrollment
Target sample size		70
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	History of inadequate response of pruritus to Topical corticosteroids or Topical calcineurin inhibitor of appropriate class with fixed-dose regimen for >=4 weeks for atopic dermatitis within the past 1 year History of inadequate response of pruritus to antihistamines or antiallergics with fixed-dose regimen/dosage for >=2 weeks for pruritus of atopic dermatitis within the past 1 year Patients who are appropriately receiving base treatment for atopic dermatitis.
	Exclusion Criteria	Patients with hepatitis B virus or hepatitis C virus, or whose parents are infected Patients with tuberculosis or suspected of tuberculosis infection Patients with immune deficiency Patients with a history or complication of hypersensitivity to immunoglobulin products Patients complicated with moderate or severe persistent asthma.
	Age Minimum	0age 6month old over
	Age Maximum	10age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pruritus of atopic dermatitis which is inadequately controlled by the currently available therapy
Intervention(s)		subcutaneous administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change from baseline in itch score weekly average at Week16
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	Medical Corporation Shintokai Yokohama Minoru Clinic Institutional Review Board
Address	1-13-8 Bessho, Minami-ku, Yokohama -City, Kanagawa
Telephone	+81-42-648-5551
E-Mail
Approval Status	Approval
Date of approval	June. 12, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Nov. 21, 2023	(this page)	Changes
2	Sept. 05, 2023	Detail	Changes
1	June. 25, 2023	Detail

List of change history