In this study participants with Progressive Pulmonary Fibrosis is evaluated for the Safety, Efficacy and Tolerability of the BMS- 986278.
Scientific Title of Study
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
IM0271015, Protocol Amendment 02, dated 03 February 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Shilpi Sinha
Designation
Associate Director,RCO Head,India
Affiliation
Bristol Myers Squibb India Pvt. Ltd
Address
BMS India Pvt. Ltd.
One International Centre, 6th Floor, Tower 1,Elphistone (W), Mumbai MAHARASHTRA Mumbai MAHARASHTRA 400013 India
Phone
02266288645
Fax
Email
shilpi.sinha@bms.com
Details of Contact Person Scientific Query
Name
Dr Kartik Doshi
Designation
Associate Director Medical India
Affiliation
Bristol Myers Squibb India Pvt. Ltd
Address
BMS India Pvt. Ltd. One International Centre, 6th Floor, Tower 1,Elphistone (W), Mumbai MAHARASHTRA Mumbai MAHARASHTRA 400013 India
Phone
02266288645
Fax
Email
kartik.doshi@bms.com
Details of Contact Person Public Query
Name
Shilpi Sinha
Designation
Associate Director,RCO Head,India
Affiliation
Bristol Myers Squibb Pvt. Ltd.
Address
BMS India Pvt. Ltd. One International Centre, 6th Floor, Tower 1,Elphistone (W), Mumbai MAHARASHTRA Mumbai MAHARASHTRA 400013 India
Phone
02266288645
Fax
Email
shilpi.sinha@bms.com
Source of Monetary or Material Support
Bristol Myers Squibb Company
Primary Sponsor
Name
Bristol-Myers Squibb Company
Address
Route 206, Province Line Road, Lawrenceville, NJ 08543
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
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 Mexico Netherlands Peru Poland Portugal Spain Switzerland Taiwan Turkey United Kingdom United States of America Malaysia Thailand
Institutional Ethics Committee, Midland Healthcare & Research Center
Approved
Ethics Committee of CIMS
Approved
Ethics Committee SMS Medical College and Attached Hospitals
Approved
Ethics Committee, N.R.S. Medical College, NRS Medical College And Hospital
Approved
GETWELL INSTITUTIONAL ETHICS COMMITTEE
Approved
Institute Ethics Committee, All India Institute of Medical Sciences
Approved
Institutional Ethics Committee SGRR Institute Of Medical Health Sciences
Approved
Institutional Ethics Committee , Fortis Hospital
Approved
Institutional Ethics Committee Charak Hospital and Research centre
Approved
Institutional Ethics Committee King Georges Medical University
Approved
Institutional Ethics Committee Poona Medical research Foundation
Approved
Institutional Ethics Committee Smt. NHL Municipal Medical College
Approved
Institutional Ethics Committee, Asthma Bhawan
Approved
Institutional Ethics Committee, KLE University KLE Dr. PK Hospital and MRC
Approved
Institutional Ethics Committee, St. John’s Medical College Hospital
Approved
Institutional Ethics Committee, The Calcutta Medical Research Institute
Approved
Institutional Ethics Committee-Ace Hospital
Approved
Jehangir Clinical Development Centre Pvt Ltd
Approved
KRIMS Ethics Committee
Approved
Max Healthcare Ethics Committee
Approved
Metro Ethical Review Board, Metro Hospitals and Heart Institute
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: J984||Other disorders of lung,
Intervention / Comparator Agent
Type
Name
Details
Intervention
BMS-986278
BMS-986278 is a Film-coated
Tablet with Unit dose 10 mg and 60 mg, administered orally twice ( Morning and Evening)
Comparator Agent
Placebo
PBO is a Film-coated
Tablet with Unit dose 10 mg and 60 mg BMS-986278, administered orally twice( Morning and Evening)
Inclusion Criteria
Age From
21.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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 defined in
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Diagnostic Criteria
for Drug and Alcohol Abuse.
h)Any other sound medical, psychiatric, and/or social reason as determined by the
investigator.
i)Adults who are subject to a legal protection measure or who are unable to express their
consent(eg, under court protection, persons not affiliated with a social security system, or
protected adults
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
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 PPF
Baseline to Week 52
Secondary Outcome
Outcome
TimePoints
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 5
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
Target Sample Size
Total Sample Size="1092" Sample Size from India="86" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/11/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
25/10/2023
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Condition/Disease: PPF
Study Hypothesis :To demonstrate the efficacy and safety of BMS-986278 60 and 120 mg BID, compared with PBO, in improving lung function by testing the absolute change in FVC (mL) from
baseline at Week 52 in participants with PPF.
Study Duration: Approximately 3 years.
Study Investigational Medicinal Product Duration: Approximately 3 years.
Health Measurement/Observation:Improvement in lung function.
Study Visit Frequency: After Week 4, visits will be every 6 weeks up to Week 52, and every 12weeks from Week 52 to EOT.