臨床研究等提出・公開システム

Date of registration	Dec. 21, 2023
Last modified on	May. 19, 2026
Trial ID	jRCT2031230526

Scientific Title	A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis with Polyangiitis
Public Title	Trial of efficacy and safety of NS-229 versus placebo in patients with Eosinophilic Granulomatosis

Contact for Scientific Queries	Name	Horiguchi Tatsuya
	Affiliation	Nippon Shinyaku Co., Ltd.
	Address	14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-120-40-8930
	E-mail	zz_mail_clinical-trials@po.nippon-shinyaku.co.jp
Contact for Public Queries	Name	Clinical Development Operations
	Affiliation	Nippon Shinyaku Co., Ltd.
	Address	14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-120-40-8930
	E-mail	zz_mail_clinical-trials@po.nippon-shinyaku.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 01, 2024
Actual date of first enrollment		May. 29, 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	(1)Male or female subjects aged >=18 years at the time the informed consent form is signed (2)Diagnosis of EGPA (3)Subjects receive background OGC dose of>=7.5 mg/day with or without stable treatment with mepolizumab or benralizumab.
	Exclusion Criteria	(1) Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis (2) Imminently life-threatening EGPA disease
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		eosinophilic granulomatosis with polyangiitis(EGPA)
Intervention(s)		Subjects receive multiple oral doses of NS-229 or placebo.
Primary Outcome(s)		The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0)* at Week 28 of the study treatment period. *Definition of remission (OGC 4.0): Birmingham Vasculitis Activity Score (BVAS) of 0 AND OGC dose of prednisolone/prednisone <=4.0 mg/day.

Primary Sponsor	NS Pharma,Inc

Primary Sponsor	Nippon Shinyaku Co., Ltd.

Name of Certified Review Board	National Hospital Organization Sagamihara National Hospital Insttutional Review Board
Address	18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa
Telephone	+81-42-742-8311
Approval Status	Approval
Date of approval	Oct. 20, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	US/Canada/UK/Germany/Italy/France/Spain

History of Changes

No	Publication date
5	May. 19, 2026	(this page)	Changes
4	April. 24, 2025	Detail	Changes
3	Aug. 31, 2024	Detail	Changes
2	Feb. 08, 2024	Detail	Changes
1	Dec. 21, 2023	Detail

List of change history