臨床研究等提出・公開システム

Date of registration	July. 31, 2020
Last modified on	Mar. 20, 2024
Trial ID	jRCT2080225297

Scientific Title	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis
Public Title	Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis (IM027-040)

Contact for Scientific Queries	Name	Sowho Mudiaga
	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	Sowho Mudiaga
	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. 03, 2020
Target Sample Size		360
Study Type		Interventional
Study Design	Study Design	Randomized, double-blind clinical trial
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	IPF Cohort: -Diagnosis of IPF within 7 years ->=40 years of age PF-ILD Cohort: -Evidence of progressive ILD within 24 months ->= 21 years of age
	Exclusion Criteria	-Women who are of childbearing potential -Smokers - Concurrent malignancy
	Minimum Age	21age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Pulmonary Fibrosis
Intervention(s)		Investigational material(s): BMS-986278 Therapeutic category code: 399 Dosage and administration: Oral administration Control material(s): Placebo Therapeutic category code: other Dosage and administration: Oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy
Secondary Outcome		safety efficacy pharmacokinetics Evaluate AEs, SAEs, laboratory test results, etc. as safety [26 weeks] Evaluate the percent change in ppFCV in PF-ILD subjects [26 weeks] Evaluate PK parameters including Cmax, Tmax, and AUC of BMS-986278 [Day1 and Week 4]

Primary Sponsor	Bristol-Myers Squibb
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB	Hamamatsu University Hospital IRB
Address of IRB	1-20-1 Handayama, Higashiku, Hamamatsu-city, Shizuoka
Phone Number of IRB	+81-53-435-2111
E-mail Address of IRB	tiken@hama-med.ac.jp
Status of IRB Review	approved
Date of Approval by IRB	June. 09, 2020

Secondary ID No.	NCT04308681
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-205393
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/South America/Europe/Oceania

History of Changes

No	Publication date
4	Mar. 20, 2024	(this page)	Changes
3	Sept. 02, 2022	Detail	Changes
2	May. 23, 2022	Detail	Changes
1	July. 31, 2020	Detail

List of change history