臨床研究等提出・公開システム

Scientific Title	ONO-4059-08:ONO-4059 Phase I Study An Open-label, Randomized, Parallel-group Comparative Study in Patients with Systemic Sclerosis
Public Title	ONO-4059-08:ONO-4059 phase 1

Contact for Scientific Queries	Name	Osawa Masahiro
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono.co.jp
Contact for Public Queries	Name	Center Information Medical
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 01, 2021
Actual date of first enrollment		Mar. 30, 2021
Target sample size		16
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.Either inpatient or outpatient 2.Patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Systemic Sclerosis 3.Patients with progressive systemic sclerosis with moderate or severe skin thickness
	Exclusion Criteria	1.Patients with serious complications associated with systemic sclerosis other than interstitial lung disease 2.Patients with severe chronic lung disease 3.Patients with serious and uncontrollable organ dysfunction not associated with systemic sclerosis 4.Patients with a disease other than systemic sclerosis that necessitates systemic corticosteroid administration within 12 weeks before the start of the observation period 5.Patients with an active infection
	Age Minimum	20age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Systemic Sclerosis
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)		Adverse events, Pharmacokinetics, Efficacy(Exploratory objective)
Secondary Outcome(s)

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	the Institutional Review Board, the University of Tokyo Hospital
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-5800-8743
E-Mail	IRBjimu-tokyo@umin.ac.jp
Approval Status	Approval
Date of approval	Feb. 24, 2021

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