A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
- Summary
- The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
- Short 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-06-04
- First posted
- 2023-08-22
- Registry last updated
- 2026-03-24
- Primary completion date
- 2026-10-06
- Start date
- 2023-09-14
- Actual participants
- 1,255
- Participants
- 1,255
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bristol-Myers Squibb
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06003426
- ClinicalTrials.gov ID
- NCT06003426
- 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: Up to 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: Up to Week 52
Cohort 2
Change from baseline in L-PF dyspnea domain score
Timeframe: Up to Week 52
Cohort 2
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
Timeframe: Up to 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 death
Timeframe: Up to approximately 3 years
Cohort 2
Change from baseline in L-PF fatigue domain score
Timeframe: Up to Week 52
Cohort 2
Change from baseline in L-PF impacts module score
Timeframe: Up to Week 52
Cohort 2
Change from baseline in cough numeric rating scale (NRS)
Timeframe: Up to Week 52
Cohort 2
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
Timeframe: Up to Week 52
Cohort 2
Change from baseline in EQ-5D-5L visual analog scale score
Timeframe: Up to Week 52
Cohort 2
Rate of decline from baseline in FVC (mL)
Timeframe: Up to Week 52
Cohort 2
Rate of decline in ppFVC from baseline
Timeframe: Up to Week 52
Cohort 2
Change in ppFVC from baseline
Timeframe: Up to Week 52
Cohort 2
Proportion of participants with absolute decline in ppFVC ≥10%
Timeframe: Up to Week 52
Cohort 2
Proportion of participants with relative decline in ppFVC ≥10%
Timeframe: Up to 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: Up to 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: Up to Week 52
Cohort 2
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
Timeframe: Up to Week 52
Cohort 2
Number of participants with Adverse Events (AEs)
Timeframe: Up to 28 days after last dose
Cohorts 1 and 2
And 7 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 40 Years
- Healthy volunteers
- No
- 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.
- 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 with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
- Other protocol-defined Inclusion/Exclusion criteria apply
- Local Institution - 0189Birmingham, United States
- Local Institution - 0361Phoenix, United States
- Local Institution - 0396La Jolla, United States
- Local Institution - 0193Los Angeles, United States
- Local Institution - 0398Los Angeles, United States
- Local Institution - 0389Orange, United States
- Local Institution - 0405Sacramento, United States
- Local Institution - 0185San Francisco, United States
- Local Institution - 0186Stanford, United States
- Local Institution - 0363Aurora, United States
- Local Institution - 0194Denver, United States
- Local Institution - 0175New Haven, United States
- Local Institution - 0151Newark, United States
- Local Institution - 0367Washington D.C., United States
- Local Institution - 0101Brandon, United States
- Local Institution - 0436Clearwater, United States
- Local Institution - 0425DeBary, United States
- Local Institution - 0079Gainesville, United States
- Local Institution - 0352Hialeah, United States
- Local Institution - 0370Kissimmee, United States
- Local Institution - 0502Leesburg, United States
- Local Institution - 0153Loxahatchee Groves, United States
- Local Institution - 0187Ocala, United States
- Local Institution - 0418Pensacola, United States
- Local Institution - 0206St. Petersburg, United States
And 365 more, listed on the interactive page.
- Related resource (www.bms.com)
- Related resource (www.bmsclinicaltrials.com)
- 2023
- 2023-503697-21
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Idiopathic pulmonary fibrosis Primary condition
- Pulmonary fibrosis