臨床研究等提出・公開システム

Scientific Title	ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus
Public Title	ONO-4059-10:Phase 3 study in patients with steroid-resistant pemphigus

Contact for Scientific Queries	Name	Osawa Masahiro
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	Medical Information Center
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Suspended

Anticipated date of first enrollment		July. 31, 2022
Actual date of first enrollment		Aug. 15, 2022
Target sample size		34
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. Patients with a diagnosis of pemphigus 2. Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of PSL equivalent
	Exclusion Criteria	1. Patients with an active infection 2. Patients with malignancy 3. Patients with past history of serious allergy or anaphylaxis
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		steroid-resistant pemphigus
Intervention(s)		ONO-4059 will be administered orally once daily after a meal.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Efficacy
Secondary Outcome(s)		Efficacy, Safety, Exploratory objective

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuou-ku, Tokyo, Tokyo
Telephone	+81-3-5213-0028
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	July. 06, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history