臨床研究等提出・公開システム

Scientific Title	A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
Public Title	Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from NASH (IM025-017)

Contact for Scientific Queries	Name	Oliveira De Claudia
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Oliveira De Claudia
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 26, 2021
Actual date of first enrollment		Mar. 17, 2021
Target sample size		270
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	-Participants with liver biopsy fibrosis score stage 4 performed within 6 months
	Exclusion Criteria	-Hepatic decompensation -Known immunocompromised status or any disease or condition which might compromise participant safety
	Age Minimum	21age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Compensated cirrhosis from NASH
Intervention(s)		Arm A: BMS-986263 low dose QW Arm B: BMS-986263 high dose QW Arm C: Placebo QW
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Improvement in liver fibrosis as determined by liver biopsy
Secondary Outcome(s)		Safety, tolerability, PK of BMS-986263

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hokkaido University Hospital Institutional Review Board
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Telephone
E-Mail
Approval Status	Approval
Date of approval	April. 28, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT04267393
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	USA (including Puerto Rico)/Canada/Brazil/Germany/Switzerland/France/Spain/Korea/Taiwan/Belgium/United Kingdom/Italy/Israel/Argentina

History of Changes

List of change history