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

• ClinicalTrials.gov Identifier: NCT06003426
• Recruitment Status: Recruiting
• First Posted: August 22, 2023
• Last Update Posted: May 7, 2024
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: August 15, 2023
• First Posted Date: August 22, 2023
• Last Update Posted Date: May 7, 2024
• Actual Study Start Date: September 14, 2023
• Estimated Primary Completion Date: October 26, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 6, 2024)

• 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

• Original Primary Outcome Measures (submitted: August 15, 2023): Absolute change from baseline in forced vital capacity (FVC) measured in mL [ Time Frame: At Week 52 ]

Current Secondary Outcome Measures (submitted: March 6, 2024)

• Number of participants who discontinued treatment due to any low BP-related Adverse Events [ Time Frame: Up to approximately 4 weeks ]
  Cohort 1
• Disease progression [ Time Frame: Up to approximately 4 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 4 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 4 years ]
  Cohort 2
• Time to absolute percent ppFVC decline of ≥ 10% from baseline [ Time Frame: Up to approximately 4 years ]
  Cohort 2
• Time to first acute exacerbation of pulmonary fibrosis [ Time Frame: Up to approximately 4 years ]
  Cohort 2
• Time to first Respiratory-related hospitalization [ Time Frame: Up to approximately 4 years ]
  Cohort 2
• Time to first pulmonary fibrosis-related hospitalization [ Time Frame: Up to approximately 4 years ]
  Cohort 2
• Time to all-cause mortality [ Time Frame: Up to approximately 4 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 ]
  Cohorts 1 and 2
• Number of participants with vital sign abnormalities [ Time Frame: Up to 28 days after last dose ]
  Cohorts 1 and 2
• Number of participants with physical examination abnormalities [ Time Frame: Up to 28 days after last dose ]
  Cohort 1

Original Secondary Outcome Measures (submitted: August 15, 2023)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic 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 Idiopathic Pulmonary Fibrosis
• Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

• Drug: BMS-986278
  Specified dose on specified days
• Drug: BMS-986278 Placebo
  Specified dose on specified days

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 15, 2023): 1185
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 26, 2026
• Estimated Primary Completion Date: October 26, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

• Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
• Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
• 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.
• 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

• 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.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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 #.

• Listed Location Countries: 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

Administrative Information

• NCT Number: NCT06003426
• Other Study ID Numbers: IM027-068
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• 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

• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: May 2024