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

  • Clinicaltrials.gov identifier

    NCT04308681

  • Recruitment Status

    Recruiting

  • First Posted

    March 16, 2020

  • Last update posted

    April 19, 2021

Study Description

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:Pulmonary Fibrosis
  • Intervention/Treatment: Other: BMS-986278 Placebo
    Drug: BMS-986278
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2020
  • Estimated Primary Completion Date: May 2023
  • Estimated Study Completion Date: December 2023

Arms and interventions

Arm Intervention/treatment
Placebo Comparator: IPF Placebo + Post Treatment Follow-up or OTE
Other: BMS-986278 Placebo
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
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
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

Outcome Measures

  • 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 ]

Eligibility Criteria

  • 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 - 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

Contacts and Locations

Contacts

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

United States, Alabama
Local Institution
Birmingham

United States, Arizona
Local Institution
Phoenix

United States, California
Local Institution
Los Angeles

United States, California
Local Institution
Los Angeles

United States, California
Local Institution
Sacramento

United States, California
Local Institution
Stanford

United States, Colorado
Local Institution
Aurora

United States, Colorado
Local Institution
Aurora

United States, Colorado
Local Institution
Denver

United States, Florida
Local Institution
Gainesville

United States, Florida
Local Institution
Gainesville

United States, Florida
Local Institution
Orlando

United States, Georgia
Local Institution
Austell

United States, Illinois
Local Institution
Chicago

United States, Kansas
University of Kansas Medical Center-Division of Pulmonary and Critical Care Medicine
Kansas City

United States, Kansas
Local Institution
Kansas City

United States, Maryland
Local Institution
Baltimore

United States, Massachusetts
Local Institution
Boston

United States, Missouri
Local Institution
Chesterfield

United States, Missouri
Local Institution
Chesterfield

United States, Missouri
Local Institution
Saint Louis

United States, Missouri
Local Institution
Saint Louis

United States, North Carolina
Local Institution
Durham

United States, Ohio
Local Institution
Cincinnati

United States, Ohio
Local Institution
Cincinnati

United States, Ohio
Local Institution
Cleveland

United States, Pennsylvania
Local Institution
Hershey

United States, Pennsylvania
Local Institution
Pittsburgh

United States, Rhode Island
Local Institution
Providence

United States, South Carolina
Local Institution
Charleston

United States, Tennessee
Local Institution
Nashville

United States, Texas
Local Institution
Dallas

United States, Utah
Local Institution
Salt Lake City

United States, Virginia
Local Institution
Charlottesville

United States, Virginia
Local Institution
Falls Church

United States, Wisconsin
Local Institution
Madison

Argentina, Buenos Aires
Local Institution
Florida

Argentina, Distrito Federal
Local Institution
Caba

Argentina, Mendoza
Local Institution
City

Argentina, Santa FE
Local Institution
Rosario

Argentina, Tucuman
Local Institution
San Miguel de Tucuman

Argentina
Local Institution
Buenos AIres

Australia, New South Wales
Royal Prince Alfred Hospital-Department of Respiratory Medicine
Camperdown

Australia, New South Wales
Westmead Hospital-Department of Respiratory and Sleep Medicine
Westmead

Australia, Queensland
The Prince Charles Hospital-Queensland Lung Transplant Service Research
Brisbane

Australia, Queensland
Gallipoli Medical Research Foundation-GMRF CTU
Greenslopes

Australia, South Australia
Royal Adelaide Hospital-Respiratory Clinical Trials Unit
Adelaide

Australia, Victoria
Austin Health-Respiratory and Sleep Medicine
Heidelberg

Australia, Western Australia
Fiona Stanley Hospital-Advanced Lung Disease Unit
Murdoch

Australia, Western Australia
Institute for Respiratory Health
Nedlands

Australia, Western Australia
Local Institution
Nedlands

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
LEuven

Belgium
Local Institution
Liège

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
São Paulo

Brazil, SAO Paulo
Local Institution
São Paulo

Brazil, SAO Paulo
Local Institution
São Paulo

Canada, British Columbia
Local Institution
Vancouver

Canada, British Columbia
Local Institution
Vancouver

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Local Institution
Québec

Canada, Quebec
Local Institution
Sherbrooke

Chile, Maule
Local Institution
Curicó

Chile, Maule
Local Institution
Talca

Chile, Valparaiso
Local Institution
Quillota

France
Local Institution
Bobigny

France
Hospices Civils de Lyon-HEMOSTASE CLINIQUE
Bron

France
Local Institution
Dijon

France
Local Institution
Marseille

France
Local Institution
Paris

France
Local Institution
Paris

France
Local Institution
Rennes

France
Local Institution
Toulouse

Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen
Essen

Germany
Local Institution
Freiburg

Germany
Robert-Bosch-Krankenhaus-Klinik-Schillerhöhe- Abteilung für Pneumologie und Beatmungsmedizin
Gerlingen

Germany
Local Institution
Gießen

Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf
Grosshandorf

Germany
KRH Klinikum Siloah-Oststadt-Heidehaus-Pneumology
Hannover

Germany
Thoraxklinik-Heidelberg gGmbH-Studienzentrum Pneumologie
Heidelberg

Germany
Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik V
Munich

Israel
Local Institution
Haifa

Israel
Local Institution
Jerusalem

Israel
Local Institution
Petah Tikva

Israel
Local Institution
Ramat Gan

Israel
Local Institution
Tel Aviv

Italy
Local Institution
Catania

Italy
Local Institution
Modena

Italy
Local Institution
Monza (MB)

Italy
Local Institution
Roma

Japan, Aichi
Local Institution
Seto

Japan, Fukushima
Local Institution
Koriyama

Japan, Hyogo
Local Institution
Kobe

Japan, Hyogo
Local Institution
Kobe

Japan, Kanagawa
Local Institution
Yokohama-Shi

Japan, Osaka
Local Institution
Sakai

Japan, Shimane
Local Institution
Izumo

Japan, Shizuoka
Local Institution
Hamamatasu

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan
Local Institution
Kumamoto

Japan
Local Institution
Nagasaki

Japan
Local Institution
Saitama

Japan
Local Institution
Tokyo

Japan
Local Institution
Tokyo

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Mexico, Distrito Federal
Local Institution
Cdmx

Mexico, Nuevo LEON
Local Institution
Monterrey, Nuevo LEON

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico, Nuevo LEON
Local Institution
San Nicolás de Los Garza

Mexico
Local Institution
Oaxaca

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Hospitalet de Llobregat

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Marbella Málaga

Spain
Local Institution
Pozuelo de Alarcon

Spain
Local Institution
Santander

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Taipei

United Kingdom
Local Institution
Cambridge

United Kingdom
Local Institution
Exeter

United Kingdom
Local Institution
London

United Kingdom
Local Institution
London

United Kingdom
Local Institution
London

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04308681 History of Changes
  • Other Study ID Numbers: IM027-040, 2019-003992-21
  • First Posted: March 16, 2020 Key Record Dates
  • Last Update Posted: April 19, 2021
  • Last Verified: April 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Interstitial lung disease
    Fibrosing interstitial lung disease
    Fibrotic interstitial lung disease
    Fibrotic interstitial pneumonia
    Idiopathic interstitial pneumonia
    Progressive Fibrotic Interstitial Lung Disease
    Idiopathic pulmonary fibrosis
  • Additional relevant MeSH terms: Fibrosis Pulmonary Fibrosis