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A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06025578
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

Condition or disease Intervention/treatment Phase
Progressive Pulmonary Fibrosis Drug: BMS-986278 Drug: BMS-986278 Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1092 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 25, 2023
Estimated Primary Completion Date : December 27, 2027
Estimated Study Completion Date : December 27, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986278 Dose 1 Drug: BMS-986278
Specified dose on specified days
Experimental: BMS-986278 Dose 2 Drug: BMS-986278
Specified dose on specified days
Placebo Comparator: BMS-986278 Placebo Drug: BMS-986278 Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants that experience spontaneous syncopal events [ Time Frame: At approximately 4 weeks ]
    Cohort 1

  2. Absolute change from baseline in forced vital capacity (FVC) measured in mL [ Time Frame: At Week 52 ]
    Cohort 2


Secondary Outcome Measures :
  1. Number of participants who discontinued treatment due to any low BP-related Adverse Events [ Time Frame: Up to approximately 3 years ]
    Cohort 1

  2. 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

  3. 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

  4. Change from baseline in L-PF dyspnea domain score [ Time Frame: At Week 52 and up to approximately 3 years ]
    Cohort 2

  5. Change from baseline in walking distance measured in 6-minute walk test (6MWT) [ Time Frame: At Week 52 ]
    Cohort 2

  6. 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

  7. Time to absolute percent ppFVC decline of ≥ 10% from baseline [ Time Frame: Up to approximately 3 years ]
    Cohort 2

  8. Time to first acute exacerbation of pulmonary fibrosis [ Time Frame: Up to approximately 3 years ]
    Cohort 2

  9. Time to first respiratory-related hospitalization [ Time Frame: Up to approximately 3 years ]
    Cohort 2

  10. Time to first pulmonary fibrosis-related hospitalization. [ Time Frame: Up to approximately 3 years ]
    Cohort 2

  11. Time to all-cause mortality [ Time Frame: Up to approximately 3 years ]
    Cohort 2

  12. Change from baseline in L-PF fatigue domain score [ Time Frame: At Week 52 and up to approximately 3 years ]
    Cohort 2

  13. Change from baseline in L-PF impacts module score [ Time Frame: At Week 52 and up to approximately 3 years ]
    Cohort 2

  14. Change from baseline in cough numeric rating scale (NRS) [ Time Frame: At Week 52 and up to approximately 3 years ]
    Cohort 2

  15. Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score [ Time Frame: At Week 52 ]
    Cohort 2

  16. Change from baseline in EQ-5D-5L visual analog scale score [ Time Frame: At Week 52 ]
    Cohort 2

  17. Rate of decline from baseline in FVC (mL) [ Time Frame: At Week 52 ]
    Cohort 2

  18. Rate of decline in ppFVC from baseline [ Time Frame: At Week 52 ]
    Cohort 2

  19. Change in ppFVC from baseline [ Time Frame: At Week 52 ]
    Cohort 2

  20. Proportion of participants with absolute decline in ppFVC ≥10% [ Time Frame: At Week 52 ]
    Cohort 2

  21. Proportion of participants with relative decline in ppFVC ≥10% [ Time Frame: At Week 52 ]
    Cohort 2

  22. 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

  23. 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

  24. Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT) [ Time Frame: At Week 52 ]
    Cohort 2

  25. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 28 days after last dose ]
    Cohort 2

  26. Number of participants with Serious AEs (SAEs) [ Time Frame: Up to 28 days after last dose ]
    Cohort 2

  27. 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

  28. Number of participants with AEs related to IMP [ Time Frame: Up to 28 days after last dose ]
    Cohort 2

  29. Number of treatment-emergent deaths [ Time Frame: Up to 28 days after last dose ]
    Cohort 2

  30. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 28 days after last dose ]
    Cohort 2

  31. Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 28 days after last dose ]
    Cohort 2

  32. Number of participants with vital sign abnormalities [ Time Frame: Up to 28 days after last dose ]
    Cohort 2


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06025578


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT06025578    
Other Study ID Numbers: IM027-1015
2023-503699-25 ( EudraCT Number )
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986278
LPA1 antagonist
Pulmonary fibrosis
Interstitial lung disease
Rheumatoid Arthritis
 Connective Tissue Disorders
Sarcoidosis
Scleroderma
Fibrosis
Antifibrotic therapy
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases