Kansas City, Kansas 66103

  • Pulmonary Fibrosis

Purpose:

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.


Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: For the idiopathic pulmonary fibrosis (IPF) Cohort - Diagnosis of IPF within 7 years - 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 - Patients with current malignancy - History of allergy to BMS-986278 or related compounds Other protocol-defined inclusion/exclusion criteria apply


Study is Available At:


Original ID:

IM027-040


NCT ID:

NCT04308681


Secondary ID:

2019-003992-21


Study Acronym:


Brief Title:

A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis


Official Title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

6


Number of Groups:

0


Total Enrollment:

360


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Primary Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information
please email:
Clinical.Trials@bms.com
Backup Contact:First line of the email MUST contain NCT # and Site #.

Study Dates

Start Date:July 29, 2020
Completion Date:December 5, 2023
Completion Type:Anticipated
Primary Completion Date:May 21, 2023
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 15, 2021
First Received Date:March 12, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants
Time Frame:Up to week 26
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of Treatment-Emergent Deaths
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time Frame:Up to 26 weeks
Safety Issues:False
Description:PR interval: The time from the onset of the P wave to the start of the QRS complex
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Time Frame:Up to 26 weeks
Safety Issues:False
Description:QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Time Frame:Up to 26 weeks
Safety Issues:False
Description:QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Time Frame:Up to 26 weeks
Safety Issues:False
Description:QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in vital signs: Body temperature
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in vital signs: Heart rate
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of clinically significant changes in physical examination findings
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of participants with ≥ 10% absolute decline in ppFVC (%)
Time Frame:At weeks 4, 8, 12, 16, and 26
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to first ≥ 10% absolute decline in ppFVC (%)
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Absolute change in FVC (mL) from baseline to Week 26
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Absolute change in ppFVC (%) from baseline to Week 26
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Absolute change in single-breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26
Time Frame:Up to week 26
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in walking endurance/distance from baseline at Week 26 as measured using the 6-Minute Walk Test (6MWT)
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of participants with acute exacerbations of lung fibrosis
Time Frame:Up to 26 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Maximum observed concentration (Cmax) of BMS-986278
Time Frame:Day 1 and Week 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time of maximum observed concentration (Tmax) of BMS-986278
Time Frame:Day 1 and Week 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Area under the plasma concentration-time curve form time 0 to 8 hours post dose of BMS-986278 (AUC(0-8))
Time Frame:Day 1 and Week 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Trough observed plasma concentration (Ctrough) of BMS-986278
Time Frame:Week 4 and Week 12
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:BMS-986278 Placebo
Description:Specified Dose on Specified Days
Arm Name:IPF Placebo + Post Treatment Follow-up or OTE
Intervention Type:Drug
Name:BMS-986278
Description:Specified Dose on Specified Days
Arm Name:IPF Dose 1 + Post Treatment Follow-up or OTE

Study Arms

Study Arm Type:Experimental
Arm Name:IPF Dose 1 + Post Treatment Follow-up or OTE
Description:IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
Study Arm Type:Experimental
Arm Name:IPF Dose 2 + Post Treatment Follow-up or OTE
Study Arm Type:Placebo Comparator
Arm Name:IPF Placebo + Post Treatment Follow-up or OTE
Study Arm Type:Experimental
Arm Name:PF-ILD Dose 1 + Post Treatment Follow-up or OTE
Description:PF-ILD (Progressive Fibrotic Interstitial Lung Disease)
Study Arm Type:Experimental
Arm Name:PF-ILD Dose 2 + Post Treatment Follow-up or OTE
Study Arm Type:Placebo Comparator
Arm Name:PF-ILD Placebo + Post Treatment Follow-up or OTE

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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