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
- Conditions
- Progressive Pulmonary Fibrosis
- Registration Number
- jRCT2021230037
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1092
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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Absolute change in FVC (mL) from baseline at Week 52
- Secondary Outcome Measures
Name Time Method