臨床研究等提出・公開システム

Scientific Title	A Phase 2, Randomized, Placebo-controlled, Double-Blind, Parallel Group, Multi-Center Study to Evaluate Efficacy and Safety of M127101 in Subjects with Nasal polyp associated with Eosinophilic Chronic Rhinosinusitis
Public Title	A Phase 2, Randomized, Placebo-controlled, Double-Blind, Parallel Group, Multi-Center Study to Evaluate Efficacy and Safety of M127101 in Subjects with Nasal polyp associated with Eosinophilic Chronic Rhinosinusitis

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		May. 10, 2024
Actual date of first enrollment		May. 16, 2024
Target sample size		45
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 with Eosinophilic Chronic Rhinosinusitis - Patients with nasal polyps in both nasal cavities - Patients with Nasal Congestion symptoms
	Exclusion Criteria	- Patients scheduled to undergo endoscopic sinus surgery during the clinical trial period - Patients with severe Asthma - Patients who cannot undergo sinus CT examination - Patients with presence of serious cardiac, hepatic, renal, pulmonary, hematologic, or other diseases considered inappropriate for participation in the clinical study - Patients who are Pregnant or breastfeeding - Patients who have not completed 120 days since participation in another clinical trial or are currently participating in another clinical trial
	Age Minimum	18age old over
	Age Maximum	79age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Nasal polyp associated with Eosinophilic Chronic Rhinosinusitis
Intervention(s)		M127101 or M127101 placebo will be administered once daily via inhalation using a nebulizer
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Nasal Polyp Score
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	Yamaguchi University Hospital Institutional Review Board
Address	1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture, Yamaguchi
Telephone	+81-836-22-2428
E-Mail	me223@yamaguchi-u.ac.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 21, 2024	(this page)	Changes
1	May. 10, 2024	Detail

List of change history