A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
- Summary
- The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
- Short 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-12-27
- First posted
- 2023-09-06
- Registry last updated
- 2026-04-23
- Primary completion date
- 2027-12-27
- Start date
- 2023-10-25
- Participants
- 1,057
- Participant count basis
- Estimated
- Planned participants
- 1,057
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bristol-Myers Squibb
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06025578
- ClinicalTrials.gov ID
- NCT06025578
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Number of participants that experience spontaneous syncopal events
Timeframe: At approximately 4 weeks
Cohort 1
Absolute change from baseline in forced vital capacity (FVC) measured in mL
Timeframe: At Week 52
Cohort 2
Number of participants who discontinued treatment due to any low BP-related Adverse Events
Timeframe: Up to approximately 3 years
Cohort 1
Disease progression
Timeframe: 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
Timeframe: At Week 52 and up to approximately 3 years
Cohort 2
Change from baseline in L-PF dyspnea domain score
Timeframe: At Week 52 and up to approximately 3 years
Cohort 2
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
Timeframe: 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
Timeframe: Up to approximately 3 years
Cohort 2
Time to absolute percent ppFVC decline of ≥ 10% from baseline
Timeframe: Up to approximately 3 years
Cohort 2
Time to first acute exacerbation of pulmonary fibrosis
Timeframe: Up to approximately 3 years
Cohort 2
Time to first respiratory-related hospitalization
Timeframe: Up to approximately 3 years
Cohort 2
Time to first pulmonary fibrosis-related hospitalization.
Timeframe: Up to approximately 3 years
Cohort 2
Time to all-cause mortality
Timeframe: Up to approximately 3 years
Cohort 2
Change from baseline in L-PF fatigue domain score
Timeframe: At Week 52 and up to approximately 3 years
Cohort 2
Change from baseline in L-PF impacts module score
Timeframe: At Week 52 and up to approximately 3 years
Cohort 2
Change from baseline in cough numeric rating scale (NRS)
Timeframe: 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
Timeframe: At Week 52
Cohort 2
Change from baseline in EQ-5D-5L visual analog scale score
Timeframe: At Week 52
Cohort 2
Rate of decline from baseline in FVC (mL)
Timeframe: At Week 52
Cohort 2
Rate of decline in ppFVC from baseline
Timeframe: At Week 52
Cohort 2
Change in ppFVC from baseline
Timeframe: At Week 52
Cohort 2
Proportion of participants with absolute decline in ppFVC ≥10%
Timeframe: At Week 52
Cohort 2
Proportion of participants with relative decline in ppFVC ≥10%
Timeframe: 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)
Timeframe: 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
Timeframe: At Week 52
Cohort 2
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
Timeframe: At Week 52
Cohort 2
Number of participants with Adverse Events (AEs)
Timeframe: Up to 28 days after last dose
Cohort 2
And 7 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 21 Years
- Healthy volunteers
- No
- 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.
- 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; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
- 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.
- Local Institution - 0046Birmingham, United States
- Local Institution - 0314Phoenix, United States
- Local Institution - 0336La Jolla, United States
- Local Institution - 0212Los Angeles, United States
- Local Institution - 0019Los Angeles, United States
- Local Institution - 0535Newport Beach, United States
- Local Institution - 0366Orange, United States
- Local Institution - 0341Sacramento, United States
- Local Institution - 0015San Francisco, United States
- Local Institution - 0352Stanford, United States
- Local Institution - 0321Aurora, United States
- Local Institution - 0376Denver, United States
- Local Institution - 0211New Haven, United States
- Local Institution - 0418Stamford, United States
- Local Institution - 0067Newark, United States
- Local Institution - 0354Washington D.C., United States
- Local Institution - 0195Brandon, United States
- Local Institution - 0380Celebration, United States
- Local Institution - 0013Clearwater, United States
- Local Institution - 0396DeBary, United States
- Local Institution - 0036Gainesville, United States
- Local Institution - 0193Gainesville, United States
- Local Institution - 0073Loxahatchee Groves, United States
- Local Institution - 0220Ocala, United States
- Local Institution - 0452Pensacola, United States
And 434 more, listed on the interactive page.
- Related resource (www.bms.com)
- Related resource (www.bmsclinicaltrials.com)
- 2023
- 2023-503699-25