臨床研究等提出・公開システム

Date of registration	Nov. 09, 2023
Last modified on	July. 10, 2025
Trial ID	jRCT2021230034

Scientific Title	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Nemolizumab in Patients with Acquired Reactive Perforating Collagenosis
Public Title	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Nemolizumab in Patients with Acquired Reactive Perforating Collagenosis

Contact for Scientific Queries	Name	Tomoyuki Nishiura
	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 Infomation
	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	Not Recruiting

Anticipated date of first enrollment		Nov. 09, 2023
Actual date of first enrollment		Dec. 04, 2023
Target sample size		21
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	Patients aged 18 years or older who have been diagnosed with acquired reactive perforating collagen fibrosis according to the diagnostic criteria of the Clinical Practice Guide for Perforated Dermatoses (2020)
	Exclusion Criteria	Patients with immune deficiency Patients with body weight less than 30.0kg Patients with Hepatitis B virus or hepatitis C virus infection Patients with Evidence of tuberculosis (TB) infection Pregnant or lactating women.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Acquired Reactive Perforating Collagenosis
Intervention(s)		subcutaneous administration
Primary Outcome(s)		Peak pruritus-Numeric rate scale (PP-NRS)

Primary Sponsor	Maruho Co.,Ltd.

Name of Certified Review Board	Institutional Review Board of Tohoku Medical and Pharmaceutical University Hospital
Address	1-12-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
Telephone	+81-22-259-1221
E-Mail	tikenn@hosp.tohoku-mpu.ac.jp
Approval Status	Approval
Date of approval	Nov. 20, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	July. 10, 2025	(this page)	Changes
4	Dec. 16, 2024	Detail	Changes
3	Sept. 03, 2024	Detail	Changes
2	April. 21, 2024	Detail	Changes
1	Nov. 09, 2023	Detail

List of change history