Phase 2
N=403
A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT04308681 ↗Enrolled (actual)
403
Serious AEs
17.1%
Results posted
Feb 2025
Primary outcome: Primary: Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants — -2.807; -3.068; -1.120 Percent change from baseline in ppFVC
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986278 Placebo (Other); BMS-986278 (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants |
-2.807; -3.068; -1.120 | — |
| SECONDARY The Number of Participants Experiencing Adverse Events (AEs) |
74; 69; 69; 32; 33; 28 | — |
| SECONDARY The Number of Participants Experiencing Serious Adverse Events (SAEs) |
16; 10; 10; 13; 4; 6 | — |
| SECONDARY The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation |
9; 9; 6; 7; 1; 0 | — |
| SECONDARY The Number of Participants Who Died Due to Adverse Events (AEs) |
2; 3; 4; 3; 0; 0 | — |
| SECONDARY Maximum Concentration (Cmax) |
465.0; 1089.8; 715.4; 1112.3; 114.66; 167.35 | — |
| SECONDARY Time to Maximum Concentration (Tmax) |
2.0170; 1.6670; 1.55; 2.01; 4.0670; 4.0330 | — |
| SECONDARY Area Under Curve (AUC0-8) |
1990.4530; 4430.5891; 3358; 4347; 686.2045; 913.4300 | — |
| SECONDARY Concentration Trough (Ctrough) |
92.1; 217; 116.0000; 286.0000; 84.2; 199 | — |
| SECONDARY The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities |
27; 18; 31; 5; 9; 12 | — |
| SECONDARY Change From Baseline in Vital Sign Measurements |
0.0; 0.0; 1.0; 3.0; 1.0; -1.0 | — |
| SECONDARY Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants |
-2.681; 2.717; -1.203 | — |
| SECONDARY The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%) |
3; 0; 2; 0; 0; 0 | — |
| SECONDARY The Number of Participants With 0% Change in ppFVC (%) |
48; 41; 33; 14; 12; 13 | — |
| SECONDARY Time to First Occurrence ≥ 10% Absolute Decline in ppFVC (%) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) |
-1.491; -0.482; 0.023; 1.119; 0.327; 0.217 | — |
| SECONDARY Absolute Change From Baseline in Forced Vital Capacity (FVC) |
-54.7; -21.2; 4.3; 39.1; 6.0; -0.30 | — |
| SECONDARY Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB) |
-0.4664; -0.3418; -0.4518; -0.2352; -0.3269; -0.1829 | — |
| SECONDARY Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB) |
-1.4634; -0.3470; -3.2455; -1.000; -1.4683; -1.4609 | — |
| SECONDARY Absolute Change From Baseline in Walking Endurance/Distance |
0.0; 3.0; 6.0; 11.0000; 0.0000; -14.0000 | — |
| SECONDARY Time to First Acute Exacerbation |
NA; NA; NA; NA; NA | — |
| SECONDARY The Number of Participants Experiencing Acute Exacerbation |
2; 3; 1; 3; 0; 1 | — |
Summary
The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.
Eligibility Criteria
Inclusion Criteria
For the idiopathic pulmonary fibrosis (IPF) Cohort
- Diagnosis of IPF within 7 years of screening
- Female and males ≥ 40 years of age
For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort
- Evidence of progressive ILD within the 24 months before screening
- Female and male ≥ 21 years of age.
Exclusion Criteria
- Women of childbearing potential (WOCBP)
- Active Smokers
- Current malignancy or previous malignancy up to 5 years prior to screening
- History of allergy to BMS-986278 or related compounds
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT04308681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.