A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis (IM027-1015)
Sowho Mudiaga
Bristol-Myers Squibb
1-2-1 Otemachi, Chiyoda-ku, Tokyo
+81-120-093-507
mg-jp-clinical_trial@bms.com
Sowho Mudiaga
Bristol-Myers Squibb
1-2-1 Otemachi, Chiyoda-ku, Tokyo
+81-120-093-507
MG-JP-RCO-JRCT@bms.com
Recruiting
Jan. 31, 2024
1092
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
>Subjects with PPF aged >= 21 years at the time of signing the informed consent
>A clinical diagnosis of ILD and >= 10% parenchymal fibrosis within the whole lung on
screening HRCT, and features consistent with progressive ILD within 24 months prior to
screening, defined as any of the following:
-Decline in relative ppFVC of >= 10%, OR
-Decline in relative ppFVC of >= 5% to < 10% and an increased extent of fibrosis on
prescreening thoracic CT compared with prior imaging, OR
-Decline in relative ppFVC of >= 5% to < 10% and symptoms associated with
progression of ILD, OR
-Symptoms associated with progression of ILD and an increased extent of fibrosis
on prescreening thoracic CT compared with prior imaging
>ppFVC >= 40%.
>Forced expiratory volume in 1 second (FEV1)/FVC >= 0.7.
>Single-breath, hemoglobin-corrected, ppDLCO >= 25%.
>If on pirfenidone or nintedanib, participants must have been receiving a stable dose for at
least 90 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
a) Diagnosis of IPF confirmed by UIP pattern.
b) Emphysema >= 50% on HRCT assessed by a central reader, or the extent of emphysema is
greater than the extent of fibrosis according to reported results from the most recent HRCT.
c) Known clinically significant pulmonary arterial hypertension (PAH) (ie, previous clinical
or echocardiographic evidence of significant right heart failure, history of right heart
catheterization showing a cardiac index < 2 L/min/m2, or PAH requiring combination of
PAH-specific therapies or any PAH parenteral therapy).
d) Acute exacerbation of pulmonary fibrosis within 4 weeks prior to or during screening.
e) Clinically significant (in the opinion of the investigator) non-parenchymal lung disease (eg,
asthma, chronic obstructive pulmonary disease, cavitary, or pleural diseases) at screening.
f) History of lung reduction surgery or lung transplant or is planning to undergo lung
transplantation or lung reduction surgery within 12 months prior to screening. Consult with
Medical Monitor if participants have had lung surgery for other non-lung fibrosis diseases
(eg, lung cancer)
g) Participants who have: 1) current malignancy; or 2) a previous malignancy within the past
5 years prior to screening are excluded, except for those with a documented history of cured
nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical
carcinoma in situ. Participants who have a biopsy that is suspicious for malignancy, and in
whom the possibility of malignancy cannot be reasonably excluded following additional
clinical, laboratory, or other diagnostic evaluations, are also excluded.
h) Clinically significant respiratory tract infection (in the opinion of the investigator) (eg,
active tuberculosis, infectious pneumonia) within 4 weeks prior to screening or during
screening. Additionally, in the case of prior SARS-CoV-2 infection, symptoms must have
completely resolved and based on investigator assessment in consultation with the Medical
Monitor, there are no sequelae that would place the participant at a higher risk of receiving
investigational treatment.
i) History of stroke or transient ischemic attack within 3 months prior to screening.
j) Significant cardiac disease within 6 months prior to screening per the investigator's opinion
(eg, hospitalization for congestive heart failure; myocardial infarction, unstable angina,
coronary angioplasty, coronary artery bypass graft, or neurocardiogenic syncope) or
uncontrolled atrial or ventricular cardiac arrhythmias.
k) Known presence of significant left-ventricular systolic dysfunction (eg, echocardiography
with ejection fraction < 40%).
l) Clinically significant cardiac involvement (eg, restrictive cardiomyopathy, or conduction
abnormalities) associated with sarcoidosis or CTD-ILD.
Note: Other protocol-defined inclusion/exclusion criteria apply
21age old over
No limit
Both
Progressive Pulmonary Fibrosis
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
Absolute change in FVC (mL) from baseline at Week 52
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 ].
4.Change in walking distance measured in 6MWT from baseline at Week 52
Bristol-Myers Squibb
Jizankai Medical Foundation Tsuboi Cancer Hospital
Argentina/Australia/Austria/Belgium/Brazil/Canada/Chile/China/Colombia/Czech Republic/Denmark/Finland/France/Germany/Greece/Hungary/India/Ireland/Israel/Italy/Mexico/Netherlands/Peru/Poland/Portugal/Republic of Korea/Spain/Sweden/Switzerland/Taiwan, Turkey, United Kingdom, United States
