臨床研究等提出・公開システム

Date of registration	Dec. 02, 2019
Last modified on	April. 08, 2024
Trial ID	jRCT2080224973

Scientific Title	An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
Public Title	Long-Term Safety and Efficacy of BMS-986165 in Subjects with Psoriasis (IM011-075)

Contact for Scientific Queries	Name	Vritzali Eleni
	Contact Name for Scientific Queries	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Phone Number	+81-120-093-507
	E-mail Address	mg-jp-clinical_trial@bms.com

Contact for Public Queries	Name	Vritzali Eleni
	Contact Name for Public Queries	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Phone Number	+81-120-093-507
	E-mail Address	MG-JP-RCO-JRCT@bms.com

Recruitment Status	completed

Date of First Enrolment		Aug. 12, 2019
Target Sample Size		60
Study Type		Interventional
Study Design	Study Design	open label, single arm
Study Design	Objective	treatment purpose
Phase		4
Key inclusion & exclusion criteria	Inclusion Criteria	-Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis -Women must not be pregnant, lactating, or breastfeeding
	Exclusion Criteria	-Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study. -To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Moderate-to-Severe Plaque Psoriasis
Intervention(s)		BMS-986165 will be administered orally at a dose of 6 mg QD.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 96 weeks ]
Secondary Outcome		-static Physician Global Assessment (sPGA)0/1 response [ Time Frame: 96 weeks ] -Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: 96 weeks ]

Primary Sponsor	Bristol-Myers Squibb
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB	Institutional Reiew Board of Tokyo Medical University Hospital
Address of IRB	6-7-1, Nishishinjuku, Sinjku-ku, Tokyo
Phone Number of IRB	+81-3-3342-6111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Nov. 12, 2019

Secondary ID No.	NCT04036435
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-195061
Name of Other Registries

Countries / Regions of Recruitment	US

History of Changes

No	Publication date
3	April. 08, 2024	(this page)	Changes
2	May. 21, 2020	Detail	Changes
1	Dec. 03, 2019	Detail

List of change history