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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04308681
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Other: BMS-986278 Placebo Drug: BMS-986278 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : November 17, 2023
Estimated Study Completion Date : November 17, 2023


Arm Intervention/treatment
Experimental: IPF Dose 1 + Post Treatment Follow-up or OTE
IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
Drug: BMS-986278
Specified Dose on Specified Days

Experimental: IPF Dose 2 + Post Treatment Follow-up or OTE Drug: BMS-986278
Specified Dose on Specified Days

Placebo Comparator: IPF Placebo + Post Treatment Follow-up or OTE Other: BMS-986278 Placebo
Specified Dose on Specified Days

Experimental: PF-ILD Dose 1 + Post Treatment Follow-up or OTE
PF-ILD (Progressive Fibrotic Interstitial Lung Disease)
Drug: BMS-986278
Specified Dose on Specified Days

Experimental: PF-ILD Dose 2 + Post Treatment Follow-up or OTE Drug: BMS-986278
Specified Dose on Specified Days

Placebo Comparator: PF-ILD Placebo + Post Treatment Follow-up or OTE Other: BMS-986278 Placebo
Specified Dose on Specified Days




Primary Outcome Measures :
  1. Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants [ Time Frame: Up to week 26 ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 26 weeks ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 26 weeks ]
  3. Incidence of Adverse Events (AEs)leading to early discontinuation of study treatment [ Time Frame: Up to 26 weeks ]
  4. Incidence of Treatment-Emergent Deaths [ Time Frame: Up to 26 weeks ]
  5. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 26 weeks ]
  6. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 26 weeks ]
  7. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 26 weeks ]
  8. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to 26 weeks ]
    PR interval: The time from the onset of the P wave to the start of the QRS complex

  9. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Up to 26 weeks ]
    QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization

  10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Up to 26 weeks ]
    QT interval: Measured from the beginning of the QRS complex to the end of the T wave

  11. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Up to 26 weeks ]
    QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)

  12. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 26 weeks ]
  13. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 26 weeks ]
  14. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 26 weeks ]
  15. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 26 weeks ]
  16. Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 26 weeks ]
  17. Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants [ Time Frame: Up to 26 weeks ]
  18. Proportion of participants with ≥ 10% absolute decline in ppFVC (%) [ Time Frame: At weeks 4, 8, 12, 16, and 26 ]
  19. Time to first ≥ 10% absolute decline in ppFVC (%) [ Time Frame: Up to 26 weeks ]
  20. Absolute change in FVC (mL) from baseline to Week 26 [ Time Frame: Up to 26 weeks ]
  21. Absolute change in ppFVC (%) from baseline to Week 26 [ Time Frame: Up to 26 weeks ]
  22. 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 ]
  23. Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26 [ Time Frame: Up to 26 weeks ]
  24. 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 ]
  25. Proportion of participants with acute exacerbations of lung fibrosis [ Time Frame: Up to 26 weeks ]
  26. Maximum observed concentration (Cmax) of BMS-986278 [ Time Frame: Day 1 and Week 4 ]
  27. Time of maximum observed concentration (Tmax) of BMS-986278 [ Time Frame: Day 1 and Week 4 ]
  28. 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 ]
  29. Trough observed plasma concentration (Ctrough) of BMS-986278 [ Time Frame: Week 4 and Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  • Diagnosis of ILD within 7 years
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308681


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 98 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04308681    
Other Study ID Numbers: IM027-040
2019-003992-21 ( EudraCT Number )
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Idiopathic pulmonary fibrosis
Progressive Fibrotic Interstitial Lung Disease
Idiopathic interstitial pneumonia
Fibrotic interstitial pneumonia
Fibrotic interstitial lung disease
Fibrosing interstitial lung disease
Interstitial lung disease
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases