Health Condition 1: J984- Other disorders of lung
Conditions
Interventions
Intervention1: BMS-986278: BMS-986278 is a Film-coated
Tablet with Unit dose 10 mg and 60 mg, administered orally twice ( Morning and Evening)
Control Intervention1: Placebo: PBO is a Film-coated
Tabl
Sponsors
Bristol-Myers Squibb Company
Eligibility
Inclusion criteria
Inclusion criteria: Signed Written Informed Consent, Type of Participant and Target Disease Characteristics-a) A clinical Diagnosis of ILD and greater than or equal too 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: (1)Decline in relative pp FVC of greater than or equal too 10%, OR(2)Decline in relative pp FVC of greater than or equal too 5% to less than 10% and an increased extent of fibrosis on prescreening thoracic CT compared with prior imaging, OR (3)Decline in relative pp FVC of greater than or equal too 5% to less than 10% and symptoms associated with progression of ILD, OR (4)Symptoms associated with progression of ILD and an increased extent of fibrosis on prescreening thoracic CT compared with prior imaging b)pp FVC greater than or equal too 40%. c)Forced expiratory volume in 1 second (FEV1)/FVC greater than or equal too 0.7 d)Single-breath, hemoglobin-corrected, pp DLCO greater than or equal too 25%. e)If on pirfenidone or nintedanib, participants must have been receiving a stable dose for at least 90 days prior to screening. f)If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within28 days prior to screening. g)Participants with sarcoidosis and other CTD-ILDs will be allowed in Cohort 2. However, participants with rheumatoid arthritis ILD are allowed in Cohort 1 and Cohort 2. h)Investigator has considered all available pulmonary fibrosis treatment options prior to obtaining informed consent. Age of Participant Participant must be greater than or equal to 21years of age at the time of signing the ICF
Exclusion criteria
Exclusion criteria: Medical Conditions a)Diagnosis of IPF confirmed by UIP pattern. b)Emphysema Greater than or equal to 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) A previous malignancy within the past 5years prior to screening are excluded, except for those with a documented history of cured non metastatic 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 a stable dose for 3 months prior to Day 1. k)Cigarette smoking (including e-cigarettes) within 3 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 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 Section 6.3: Lifestyle Restrictions. c)Participation in another interventional clinical trial concurrent with this study. d)Any gastrointestinal surgery or condition that in the opinion of the investigator would impact the absorption of IMP. e)Inability to tolerate PO medication. f)Inability to be veni punctured and/or tolerate venous access. g)Recent (within 6 months of IMP administration) drug or alcohol abuse as defin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of 2doses of BMS-986278, 60 mg and 120 mg BID, compared with PBO, in demonstrating improvement in absolute change in FVC from baseline at Week 52 in participants with PPFTimepoint: Baseline to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of BMS-98627860 and 120 mgBID, compared with PBO ,on disease progression from baseline through EOT To evaluate the effect of BMS-98627860 and 120 mg BID, compared with PBO, on quality of life and morbidity from baseline to Week 5Timepoint: 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, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactShilpi Sinha
Bristol Myers Squibb India Pvt. Ltd
Outcome results
None listed