Health Condition 1: J984- Other disorders of lung
Conditions
Interventions
Intervention1: BMS-986278: BMS-986278 is Film- coated Tablet with Unit dose of 10 mg and 60 mg, administered Orally twice ( Morning and Evening)
Control Intervention1: Placebo: PBO Film- coated Table
Sponsors
Bristol-Myers Squibb Company
BMS India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Signed Written Informed Consent Type of Participant and Target Disease Characteristics a)Diagnosis of IPF within 7 years prior to screening b)Diagnosis of IPF is supported by centrally read chest high-resolution computed tomography (HRCT)obtained during screening i)HRCT interpretation is consistent with definite UIP or probable UIP ii)If the HRCT interpretation on central reading is inconsistent with UIP (indeterminate or most consistent with non-IPF diagnosis)there must be verification that surgical lung biopsy histopathology is consistent with UIP. UIP pattern identification via cryobiopsy or by genomic classifier will be considered on a case-by-case basis (in collaboration with the Medical Monitor and central BMS study team) c)ppFVC greater than or equal too 40% d)Forced expiratory volume in 1 second (FEV1)/FVC greater than or equal too 0.7 e)Single-breath, hemoglobin-corrected ppDLCO greater than or equal too 25% f)If on pirfenidone or nintedanib participants must have been receiving a stable dose for at least 90 days prior to screening g)If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening h)Investigator has considered all available IPF treatment options prior to obtaining informed consent Reproductive Status 1)Investigators shall counsel women of childbearing potential (WOCBP) (as defined in Appendix 4) participants, and male participants who are sexually active with WOCBP,on the importance of pregnancy prevention, the implications of an unexpected pregnancy and the potential of fetal toxicity occurring due to transmission of IMP, present in seminal fluid, to a developing fetus, even if the participant has undergone a successful vasectomy or if the partner is pregnant. 2)The investigator shall evaluate the effectiveness of the contraceptive method. 3)Local laws and regulations may require the use of alternative and/or additional contraception methods
Exclusion criteria
Exclusion criteria: Medical Conditions a)ILD associated with known primary causes (eg, hypersensitivity pneumonitis, autoimmune associated ILD, sarcoidosis, etc.). b)Emphysema greater than equal too 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)Acute exacerbation of pulmonary fibrosis within 4 weeks prior to or during screening. d)Clinically significant (in the opinion of the investigator)non-parenchymal lung disease (eg,asthma, chronic obstructive pulmonary disease, cavitary, or pleural diseases)at screening. e) Participants who have: 1) Current malignancy; or 2) Aprevious malignancy within the past 5years 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. f) 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. g) History of stroke or transient ischemic attack within 3months prior to screening. h) Exhibit symptoms of heart failure at rest. I) History of lung reduction surgery or lung transplant. Note:being on transplantation list is allowed. J)Participant has known pulmonary arterial hypertension (PAH) that requires multi-drug therapy. Note: Single drug therapy is permitted provided the participant is on astable dose for 3months prior to Day 1. k)Cigarette smoking (including e-cigarettes) within3 months before Day1. L)History of persistent or active post-micturition/defecation and anamnestic known syncope. M)History of persistent or active postural orthostatic tachycardia syndrome. N)Symptomatic bradycardia or second-or third-degree heart block. O)Symptomatic valvular heart disease including mitral stenosis, aortic stenosis, bicuspid aortic valve. p)Aortic dissection requiring surgery or intervention Reproductive Status a)Women who are pregnant or breastfeeding. b)Positive pregnancy test from screeningto Day 1 (prior to IMP administration). Other Exclusion Criteria a)Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply,and Sponsor approval is required.). b)Inability to comply with restrictions as listed in Lifestyle Restrictions. c)Participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of 2doses of BMS-986278, 60 and 120 mg BID, compared with PBO, in demonstrating improvement in absolute change in FVC from baseline at Week 52.Timepoint: baseline to Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of BMS-986278,60 and 120 mg BID, compared with PBO, on disease progression from baseline through EOT To evaluate the effect of BMS-98627860 and 120 mg BID ,compared withPBO, on quality of life and morbidity from baseline to Week 52Timepoint: Change in L-PF cough domain score from baseline at Week 52 Change in walking distance measured in 6MWT from baseline at Week 52 Change in L-PF dyspnea domain score from baseline at Week 52 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Democratic People's Republic of Korea, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Spain, Swaziland, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactShilpi Sinha
Bristol Myers Squibb India Pvt. Ltd.
Outcome results
None listed