臨床研究等提出・公開システム

Date of registration	Oct. 20, 2017
Last modified on	Dec. 18, 2024
Trial ID	jRCT2080223685

Scientific Title	A Phase I, Open-label Single Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nemolizumab in Pediatric Patients With Atopic Dermatitis
Public Title	A Phase I, Open-label Single Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nemolizumab in Pediatric Patients With Atopic Dermatitis

Contact for Scientific Queries	Name	Nishiura Tomoyuki
	Contact Name for Scientific Queries	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 Chudoji Awatacho, Shimogyo-ku, Kyoto
	Phone Number	+81-75-325-3279
	E-mail Address	ctinfo@mii.maruho.co.jp

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

Recruitment Status	completed

Date of First Enrolment		Oct. 18, 2017
Target Sample Size		18
Study Type		Interventional
Study Design	Study Design	Open-label, Multi-Center, Inter-individual dose escalation, Pharmacokinetics Study.
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Atopic Dermatitis with moderate or severe pruritus
	Exclusion Criteria	1. Patients with Hepatitis B virus or hepatitis C virus infection 2. Patients with Evidence of tuberculosis (TB) infection 3. Patients with moderate or severe asthema symptoms 4. Patients with immune deficiency
	Minimum Age	6age old over
	Maximum Age	12age old under
	Gender	Both
Health Condition or Problem Studied		Atopic dermatitis with pruritus who are inadequately controlled by existing therapies
Intervention(s)		investigational material(s) Generic name etc : nemolizumab INN of investigational material : nemolizumab Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : subcutaneous administration control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		pharmacokinetics Pharmacokinetics Serum concentration of nemolizumab
Secondary Outcome		safety efficacy Safety assessmemt Adverse event/Laboratory tests/Vital signs/ECG

Primary Sponsor	Maruho Co.,Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Fukuoka Children's Hospital Institutional Review Board
Address of IRB	5-1-1 Kashiiteriha, Higashi-ku, Fukuoka, Fukuoka, JAPAN
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 02, 2017

Secondary ID No.	JapicCTI-173741
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	Dec. 18, 2024	(this page)	Changes
6	Jan. 29, 2020	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	Dec. 11, 2018	Detail	Changes
3	Dec. 11, 2018	Detail	Changes
2	Oct. 20, 2017	Detail	Changes
1	Oct. 20, 2017	Detail

List of change history