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

Phase 3

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: BMS-986278; Drug: BMS-986278 Placebo

• Registration Number: NCT06003426
• Lead Sponsor: Bristol-Myers Squibb

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 available

Study Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-22
• Study Start: 2023-09-14
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-18
• Primary Completion: 2026-10-26
• Study Completion: 2026-10-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1185

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-986278 Dose 1	BMS-986278	-
BMS-986278 Dose 2	BMS-986278	-
BMS-986278 Placebo	BMS-986278 Placebo	-

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in forced vital capacity (FVC) measured in mL	Up to Week 52	Cohort 2
Number of participants that experience spontaneous syncopal events	At approximately 4 weeks	Cohort 1

Secondary Outcome Measures

Name	Time	Method
Number of participants who discontinued treatment due to any low BP-related Adverse Events	Up to approximately 3 years	Cohort 1
Disease progression	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	Up to Week 52	Cohort 2
Change from baseline in L-PF dyspnea domain score	Up to Week 52	Cohort 2
Change from baseline in walking distance measured in 6-minute walk test (6MWT)	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	Up to approximately 3 years	Cohort 2
Time to absolute percent ppFVC decline of ≥ 10% from baseline	Up to approximately 3 years	Cohort 2
Time to first acute exacerbation of pulmonary fibrosis	Up to approximately 3 years	Cohort 2
Time to first Respiratory-related hospitalization	Up to approximately 3 years	Cohort 2
Time to first pulmonary fibrosis-related hospitalization	Up to approximately 3 years	Cohort 2
Time to death	Up to approximately 3 years	Cohort 2
Change from baseline in L-PF fatigue domain score	Up to Week 52	Cohort 2
Change from baseline in L-PF impacts module score	Up to Week 52	Cohort 2
Change from baseline in cough numeric rating scale (NRS)	Up to Week 52	Cohort 2
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score	Up to Week 52	Cohort 2
Change from baseline in EQ-5D-5L visual analog scale score	Up to Week 52	Cohort 2
Rate of decline from baseline in FVC (mL)	Up to Week 52	Cohort 2
Rate of decline in ppFVC from baseline	Up to Week 52	Cohort 2
Change in ppFVC from baseline	Up to Week 52	Cohort 2
Proportion of participants with absolute decline in ppFVC ≥10%	Up to Week 52	Cohort 2
Proportion of participants with relative decline in ppFVC ≥10%	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)	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	Up to Week 52	Cohort 2
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)	Up to Week 52	Cohort 2
Number of participants with Adverse Events (AEs)	Up to 28 days after last dose	Cohort 2
Number of participants with Serious AEs (SAEs)	Up to 28 days after last dose	Cohort 2
Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)	Up to 28 days after last dose	Cohort 2
Number of participants with AEs related to IMP	Up to 28 days after last dose	Cohort 2
Number of treatment-emergent deaths	Up to 28 days after last dose	Cohort 2
Number of participants with clinical laboratory abnormalities	Up to 28 days after last dose	Cohort 2
Number of participants with electrocardiogram (ECG) abnormalities	Up to 28 days after last dose	Cohorts 1 and 2
Number of participants with vital sign abnormalities	Up to 28 days after last dose	Cohorts 1 and 2
Number of participants with physical examination abnormalities	Up to 28 days after last dose	Cohort 1

Trial Locations

Locations (503)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0179; 🇺🇸 Jasper, Alabama, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Scripps Clinic Torrey Pines; 🇺🇸 La Jolla, California, United States

Local Institution - 0112; 🇺🇸 La Jolla, California, United States

University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic; 🇺🇸 Los Angeles, California, United States

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

Local Institution - 0501; 🇺🇸 Newport Beach, California, United States

UC Irvine Medical Center; 🇺🇸 Orange, California, United States

University of California UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Scroll for more (493 remaining)