臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 29, 2023
Last modified on	Sept. 29, 2023
Trial ID	jRCT2021230026

Scientific Title	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
Public Title	A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis (IM027-068)

Contact for Scientific Queries	Name	Wang Yan
	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	Wang Yan
	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		Oct. 26, 2023
Actual date of first enrollment
Target sample size		1185
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	Subjects with IPF aged >= 40 years at the time of signing the informed consent Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia. If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening. Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test Men who are sexually active with women of childbearing potential agree to use male barrier contraception
	Exclusion Criteria	History of stroke or transient ischemic attack within 3 months prior to screening Significant cardiac disease within 6 months prior to screening per the investigator's discretion Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ. Note: Other protocol-defined inclusion/exclusion criteria apply
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Idiopathic Pulmonary Fibrosis
Intervention(s)		Experimental: BMS-986278 Dose 1 : BMS-986278 Specified dose on specified days Experimental: BMS-986278 Dose 2: BMS-986278 Specified dose on specified days Placebo Comparator: BMS-986278 Placebo: BMS-986278 Placebo Specified dose on specified days
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Absolute change from baseline in forced vital capacity (FVC) measured in mL [ Time Frame: At Week 52 ]
Secondary Outcome(s)		1.Disease progression [ Time Frame: Up to approximately 4 years ] 2.Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score [ Time Frame: At Week 52 and up to approximately 4 years ] 3.Change from baseline in L-PF dyspnea domain score [ Time Frame: At Week 52 and up to approximately 4 years ] etc.

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Jizankai Medical Foundation Tsuboi Cancer Hospital
Address	1-10-13 Nagakubo, Asaka-machi, Koriyama-shi, Fukushima, Fukushima
Telephone	+81-24-946-0808
E-Mail
Approval Status	Approval
Date of approval	Sept. 08, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	US