Back to resultsA Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
Primary Purpose
Progressive Pulmonary Fibrosis
Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BMS-986278
BMS-986278 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Pulmonary Fibrosis focused on measuring BMS-986278, LPA1 antagonist, Pulmonary fibrosis, Interstitial lung disease, Rheumatoid Arthritis, Connective Tissue Disorders, Sarcoidosis, Scleroderma, Fibrosis, Antifibrotic therapy
Eligibility Criteria
Inclusion Criteria: Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of disease 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), 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. Systemic corticosteroids are permitted provided that the participant is on prednisone ≤ 15 mg/day or equivalent for at least 70 days prior to Day 1. 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 Significant cardiac disease within 6 months prior to screening per the investigator's discretion 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. Note: Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Stanford Hospital and Clinics
- University Hospitals Cleveland Medical Center
- Local Institution - 0110
- Local Institution - 0258
- Local Institution - 0306
- Local Institution - 0164
- Local Institution - 0179
- Local Institution - 0178
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
BMS-986278 Dose 1
BMS-986278 Dose 2
BMS-986278 Placebo
Arm Description
Outcomes
Primary Outcome Measures
Absolute change from baseline in forced vital capacity (FVC) measured in mL
Secondary Outcome Measures
Disease progression
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
Change from baseline in L-PF dyspnea domain score
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
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 to absolute percent ppFVC decline of ≥ 10% from baseline
Time to first acute exacerbation of pulmonary fibrosis
Time to first lung fibrosis-related hospitalization
Time to all-cause mortality
Change from baseline in L-PF fatigue domain score
Change from baseline in L-PF impact module score
Change from baseline in cough numeric rating scale (NRS)
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
Change from baseline in EQ-5D-5L visual analog scale score
Rate of decline from baseline in FVC (mL)
Rate of decline in ppFVC from baseline
Change in ppFVC from baseline
Proportion of participants with absolute decline in ppFVC ≥10%
Proportion of participants with relative decline in ppFVC ≥10%
Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)
Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
Number of participants with Adverse Events (AEs)
Number of participants with Serious AEs (SAEs)
Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)
Number of treatment-emergent deaths
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with vital sign abnormalities
Full Information
NCT ID
NCT06025578
First Posted
August 30, 2023
Last Updated
September 11, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT06025578
Brief Title
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 18, 2023 (Anticipated)
Primary Completion Date
December 27, 2027 (Anticipated)
Study Completion Date
December 27, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Pulmonary Fibrosis
Keywords
BMS-986278, LPA1 antagonist, Pulmonary fibrosis, Interstitial lung disease, Rheumatoid Arthritis, Connective Tissue Disorders, Sarcoidosis, Scleroderma, Fibrosis, Antifibrotic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1092 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMS-986278 Dose 1
Arm Type
Experimental
Arm Title
BMS-986278 Dose 2
Arm Type
Experimental
Arm Title
BMS-986278 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986278
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986278 Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Absolute change from baseline in forced vital capacity (FVC) measured in mL
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Disease progression
Description
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
Time Frame
Up to approximately 4 years
Title
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
Title
Change from baseline in L-PF dyspnea domain score
Time Frame
At Week 52 and up to approximately 4 years
Title
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
Time Frame
At Week 52
Title
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
Title
Time to absolute percent ppFVC decline of ≥ 10% from baseline
Time Frame
Up to approximately 4 years
Title
Time to first acute exacerbation of pulmonary fibrosis
Time Frame
Up to approximately 4 years
Title
Time to first lung fibrosis-related hospitalization
Time Frame
Up to approximately 4 years
Title
Time to all-cause mortality
Time Frame
Up to approximately 4 years
Title
Change from baseline in L-PF fatigue domain score
Time Frame
At Week 52 and up to approximately 4 years
Title
Change from baseline in L-PF impact module score
Time Frame
At Week 52 and up to approximately 4 years
Title
Change from baseline in cough numeric rating scale (NRS)
Time Frame
At Week 52 and up to approximately 4 years
Title
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
Time Frame
At Week 52
Title
Change from baseline in EQ-5D-5L visual analog scale score
Time Frame
At Week 52
Title
Rate of decline from baseline in FVC (mL)
Time Frame
At Week 52
Title
Rate of decline in ppFVC from baseline
Time Frame
At Week 52
Title
Change in ppFVC from baseline
Time Frame
At Week 52
Title
Proportion of participants with absolute decline in ppFVC ≥10%
Time Frame
At Week 52
Title
Proportion of participants with relative decline in ppFVC ≥10%
Time Frame
At Week 52
Title
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
Title
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
Title
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
Time Frame
At Week 52
Title
Number of participants with Adverse Events (AEs)
Time Frame
Up to 28 days after last dose
Title
Number of participants with Serious AEs (SAEs)
Time Frame
Up to 28 days after last dose
Title
Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)
Time Frame
Up to 28 days after last dose
Title
Number of treatment-emergent deaths
Time Frame
Up to 28 days after last dose
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 28 days after last dose
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 28 days after last dose
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 28 days after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of disease 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), 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.
Systemic corticosteroids are permitted provided that the participant is on prednisone ≤ 15 mg/day or equivalent for at least 70 days prior to Day 1.
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
Significant cardiac disease within 6 months prior to screening per the investigator's discretion
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.
Note: Other protocol-defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rishi Raj, Site 0352
Phone
650-736-8083
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maroun Matta, Site 0186
Phone
216-844-8447
Facility Name
Local Institution - 0110
City
Aarhus
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0110
Facility Name
Local Institution - 0258
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution - 0306
City
Jongno-gu
State/Province
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0306
Facility Name
Local Institution - 0164
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0164
Facility Name
Local Institution - 0179
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0179
Facility Name
Local Institution - 0178
City
Santander
State/Province
CB
ZIP/Postal Code
39010
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0178
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
See plan description
IPD Sharing Access Criteria
See plan description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
Learn more about this trial
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
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