August 30, 2023
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September 6, 2023
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May 14, 2024
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October 25, 2023
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December 27, 2027 (Final data collection date for primary outcome measure)
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- Number of participants that experience spontaneous syncopal events [ Time Frame: At approximately 4 weeks ]
Cohort 1
- Absolute change from baseline in forced vital capacity (FVC) measured in mL [ Time Frame: At Week 52 ]
Cohort 2
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Absolute change from baseline in forced vital capacity (FVC) measured in mL [ Time Frame: At Week 52 ]
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- Number of participants who discontinued treatment due to any low BP-related Adverse Events [ Time Frame: Up to approximately 3 years ]
Cohort 1
- Disease progression [ Time Frame: Up to approximately 3 years ]
Cohort 2
Disease progression will be measured by the time to first disease progression event in at least 1 of the following parameters:
- Absolute percent predicted forced vital capacity (ppFVC) decline of ≥ 10% from baseline
- Acute exacerbation of pulmonary fibrosis
- Respiratory-related hospitalization
- All-cause mortality
- Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score [ Time Frame: At Week 52 and up to approximately 3 years ]
Cohort 2
- Change from baseline in L-PF dyspnea domain score [ Time Frame: At Week 52 and up to approximately 3 years ]
Cohort 2
- Change from baseline in walking distance measured in 6-minute walk test (6MWT) [ Time Frame: At Week 52 ]
Cohort 2
- Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first respiratory-related hospitalization, or all-cause mortality [ Time Frame: Up to approximately 3 years ]
Cohort 2
- Time to absolute percent ppFVC decline of ≥ 10% from baseline [ Time Frame: Up to approximately 3 years ]
Cohort 2
- Time to first acute exacerbation of pulmonary fibrosis [ Time Frame: Up to approximately 3 years ]
Cohort 2
- Time to first respiratory-related hospitalization [ Time Frame: Up to approximately 3 years ]
Cohort 2
- Time to first pulmonary fibrosis-related hospitalization. [ Time Frame: Up to approximately 3 years ]
Cohort 2
- Time to all-cause mortality [ Time Frame: Up to approximately 3 years ]
Cohort 2
- Change from baseline in L-PF fatigue domain score [ Time Frame: At Week 52 and up to approximately 3 years ]
Cohort 2
- Change from baseline in L-PF impacts module score [ Time Frame: At Week 52 and up to approximately 3 years ]
Cohort 2
- Change from baseline in cough numeric rating scale (NRS) [ Time Frame: At Week 52 and up to approximately 3 years ]
Cohort 2
- Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score [ Time Frame: At Week 52 ]
Cohort 2
- Change from baseline in EQ-5D-5L visual analog scale score [ Time Frame: At Week 52 ]
Cohort 2
- Rate of decline from baseline in FVC (mL) [ Time Frame: At Week 52 ]
Cohort 2
- Rate of decline in ppFVC from baseline [ Time Frame: At Week 52 ]
Cohort 2
- Change in ppFVC from baseline [ Time Frame: At Week 52 ]
Cohort 2
- Proportion of participants with absolute decline in ppFVC ≥10% [ Time Frame: At Week 52 ]
Cohort 2
- Proportion of participants with relative decline in ppFVC ≥10% [ Time Frame: At Week 52 ]
Cohort 2
- Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg) [ Time Frame: At Week 52 ]
Cohort 2
- Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline [ Time Frame: At Week 52 ]
Cohort 2
- Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT) [ Time Frame: At Week 52 ]
Cohort 2
- Number of participants with Adverse Events (AEs) [ Time Frame: Up to 28 days after last dose ]
Cohort 2
- Number of participants with Serious AEs (SAEs) [ Time Frame: Up to 28 days after last dose ]
Cohort 2
- Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP) [ Time Frame: Up to 28 days after last dose ]
Cohort 2
- Number of participants with AEs related to IMP [ Time Frame: Up to 28 days after last dose ]
Cohort 2
- Number of treatment-emergent deaths [ Time Frame: Up to 28 days after last dose ]
Cohort 2
- Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 28 days after last dose ]
Cohort 2
- Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 28 days after last dose ]
Cohort 2
- Number of participants with vital sign abnormalities [ Time Frame: Up to 28 days after last dose ]
Cohort 2
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- Disease progression [ Time Frame: Up to approximately 4 years ]
Disease progression will be measured by the time to first disease progression event in at least 1 of the following parameters:
- Absolute percent predicted forced vital capacity (ppFVC) decline of ≥ 10% from baseline
- Acute exacerbation of pulmonary fibrosis
- Lung fibrosis-related hospitalization
- All-cause mortality
- 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 ]
- Change from baseline in L-PF dyspnea domain score [ Time Frame: At Week 52 and up to approximately 4 years ]
- Change from baseline in walking distance measured in 6-minute walk test (6MWT) [ Time Frame: At Week 52 ]
- Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first Lung fibrosis-related hospitalization, or all-cause mortality [ Time Frame: Up to approximately 4 years ]
- Time to absolute percent ppFVC decline of ≥ 10% from baseline [ Time Frame: Up to approximately 4 years ]
- Time to first acute exacerbation of pulmonary fibrosis [ Time Frame: Up to approximately 4 years ]
- Time to first lung fibrosis-related hospitalization [ Time Frame: Up to approximately 4 years ]
- Time to all-cause mortality [ Time Frame: Up to approximately 4 years ]
- Change from baseline in L-PF fatigue domain score [ Time Frame: At Week 52 and up to approximately 4 years ]
- Change from baseline in L-PF impact module score [ Time Frame: At Week 52 and up to approximately 4 years ]
- Change from baseline in cough numeric rating scale (NRS) [ Time Frame: At Week 52 and up to approximately 4 years ]
- Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score [ Time Frame: At Week 52 ]
- Change from baseline in EQ-5D-5L visual analog scale score [ Time Frame: At Week 52 ]
- Rate of decline from baseline in FVC (mL) [ Time Frame: At Week 52 ]
- Rate of decline in ppFVC from baseline [ Time Frame: At Week 52 ]
- Change in ppFVC from baseline [ Time Frame: At Week 52 ]
- Proportion of participants with absolute decline in ppFVC ≥10% [ Time Frame: At Week 52 ]
- Proportion of participants with relative decline in ppFVC ≥10% [ Time Frame: At Week 52 ]
- Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg) [ Time Frame: At Week 52 ]
- Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline [ Time Frame: At Week 52 ]
- Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT) [ Time Frame: At Week 52 ]
- Number of participants with Adverse Events (AEs) [ Time Frame: Up to 28 days after last dose ]
- Number of participants with Serious AEs (SAEs) [ Time Frame: Up to 28 days after last dose ]
- Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP) [ Time Frame: Up to 28 days after last dose ]
- Number of treatment-emergent deaths [ Time Frame: Up to 28 days after last dose ]
- Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 28 days after last dose ]
- Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 28 days after last dose ]
- Number of participants with vital sign abnormalities [ Time Frame: Up to 28 days after last dose ]
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Not Provided
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Not Provided
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A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
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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
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
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Not Provided
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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Progressive Pulmonary Fibrosis
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- Experimental: BMS-986278 Dose 1
Intervention: Drug: BMS-986278
- Experimental: BMS-986278 Dose 2
Intervention: Drug: BMS-986278
- Placebo Comparator: BMS-986278 Placebo
Intervention: Drug: BMS-986278 Placebo
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Not Provided
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Recruiting
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1092
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Same as current
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December 27, 2027
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December 27, 2027 (Final data collection date for primary outcome measure)
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Inclusion Criteria
- Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
- If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
- If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
- Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
- Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
- Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 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.
Exclusion Criteria
- Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
- History of stroke or transient ischemic attack within 3 months prior to screening.
- Participants who exhibit symptoms of heart failure at rest.
- Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
- Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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Sexes Eligible for Study: |
All |
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21 Years and older (Adult, Older Adult)
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No
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com |
855-907-3286 |
Clinical.Trials@bms.com |
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Contact: First line of the email MUST contain the NCT# and Site #. |
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Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
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NCT06025578
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IM027-1015 2023-503699-25 ( EudraCT Number )
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Plan to Share IPD: |
Yes |
Plan Description: |
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html |
Supporting Materials: |
Study Protocol |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Supporting Materials: |
Clinical Study Report (CSR) |
Time Frame: |
See plan description |
Access Criteria: |
See plan description |
URL: |
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html |
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Bristol-Myers Squibb
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Same as current
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Bristol-Myers Squibb
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Same as current
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Not Provided
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Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
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Bristol-Myers Squibb
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May 2024
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