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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

    Active, not recruiting

  • First Posted

    March 16, 2020

  • Last update posted

    September 23, 2022

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
  • Actual Enrollment: 373 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
  • Actual Study Start Date: July 2020
  • Estimated Primary Completion Date: August 2022
  • Actual Study Completion Date: September 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. Absolute change in ppFVC (%) from baseline to Week 26 [ Time Frame: Up to 26 weeks ]
  • 2. 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 ]
  • 3. Trough observed plasma concentration (Ctrough) of BMS-986278 [ Time Frame: Week 4 and Week 12 ]
  • 4. Incidence of Adverse Events (AEs) [ Time Frame: Up to 26 weeks ]
  • 5. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 26 weeks ]
  • 6. Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment [ Time Frame: Up to 26 weeks ]
  • 7. Incidence of Treatment-Emergent Deaths [ Time Frame: Up to 26 weeks ]
  • 8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 26 weeks ]
  • 9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 26 weeks ]
  • 10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 26 weeks ]
  • 11. 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
  • 12. 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
  • 13. 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
  • 14. 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)
  • 15. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 26 weeks ]
  • 16. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 26 weeks ]
  • 17. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 26 weeks ]
  • 18. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 26 weeks ]
  • 19. Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 26 weeks ]
  • 20. Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants [ Time Frame: Up to 26 weeks ]
  • 21. Proportion of participants with ≥ 10% absolute decline in ppFVC (%) [ Time Frame: At weeks 4, 8, 12, 16, 20, and 26 ]
  • 22. Proportion of participants with > 0% change in ppFVC [ Time Frame: At weeks 4, 8, 12, 16, 20, and 26 ]
  • 23. Time to first acute exacerbation [ Time Frame: Up to 26 weeks ]
  • 24. Time to first ≥ 10% absolute decline in ppFVC (%) [ Time Frame: Up to 26 weeks ]
  • 25. Absolute change in FVC (mL) from baseline to Week 26 [ Time Frame: Up to 26 weeks ]
  • 26. 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 26 weeks ]
  • 27. Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26 [ Time Frame: Up to 26 weeks ]
  • 28. 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 ]
  • 29. Proportion of participants with acute exacerbations of lung fibrosis [ Time Frame: Up to 26 weeks ]
  • 30. Maximum observed concentration (Cmax) of BMS-986278 [ Time Frame: Day 1 and Week 4 ]
  • 31. Time of maximum observed concentration (Tmax) of BMS-986278 [ Time Frame: Day 1 and Week 4 ]

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Locations

China
Local Institution
Shanghai

China, Hubei
Local Institution - 0188
Wuhan

China, Beijing
Local Institution - 0187
Beijing

China, Beijing
Local Institution
Beijing

France
Local Institution - 0120
Bobigny

France
Local Institution - 0066
Bron

France
Local Institution - 0136
Dijon

France
Local Institution - 0162
Marseille

France
Hopital Europeen Georges Pompidou
Paris

France
Local Institution - 0143
Paris

France
Local Institution - 0067
Rennes

France
Local Institution - 0132
Toulouse

United States, Alabama
University of Alabama at Birmingham-Division of Pulmonary, Allergy & Critical Care Med
Birmingham

United States, Arizona
Local Institution
Phoenix

United States, California
UCLA-Peter Morton Medical Building
Los Angeles

United States, California
Stanford University
Stanford

United States, Colorado
University of Colorado Anschutz Medical Campus-Department of Medicine
Aurora

United States, Colorado
National Jewish Health Medical Center
Denver

United States, Connecticut
Local Institution
New Haven

United States, Florida
University of Florida College of Medicine-Pulmonary, Critical Care and Sleep medicine
Gainesville

United States, Florida
Central Florida Pulmonary Group-Research
Orlando

United States, Georgia
Local Institution - 0078
Atlanta

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

United States, Maryland
Johns Hopkins Bayview Medical Center-Johns Hopkins Asthma & Allergy Center
Baltimore

United States, Massachusetts
Steward St. Elizabeth's Clinical Laboratory
Boston

United States, Missouri
The Lung Research Center-The Lung Research Center
Chesterfield

United States, Missouri
Washington University School Of Medicine
Saint Louis

United States, Ohio
University of Cincinnati Medical Center-Division of Pulmonary, Critical Care and Sleep Medicine
Cincinnati

United States, Ohio
Ohio State University
Columbus

United States, Pennsylvania
Local Institution
Hershey

United States, Tennessee
Local Institution
Nashville

United States, Virginia
University of Virginia Health System-Division of Pulmonary and Critical Care Medicine
Charlottesville

United States, Virginia
Local Institution
Falls Church

Argentina, Buenos Aires
Local Institution
Florida

Argentina, Distrito Federal
Local Institution - 0049
Buenos Aires

Argentina, Mendoza
Local Institution
City

Argentina, Santa FE
Local Institution
Rosario

Argentina, Tucuman
Local Institution
San Miguel de Tucuman

Argentina
Local Institution - 0115
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
Local Institution - 0026
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

Belgium
Local Institution - 0074
Brussels

Belgium
Local Institution - 0065
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
Local Institution - 0076
Sao Paulo

Canada, British Columbia
Local Institution - 0141
Vancouver

Canada, British Columbia
Local Institution
Vancouver

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution - 0094
Montréal

Canada, Quebec
Local Institution
Québec

Canada, Quebec
Local Institution - 0144
Sherbrooke

Chile, Maule
Local Institution - 0108
Curicó

Chile, Maule
Local Institution - 0054
Talca

Chile, Valparaiso
Local Institution - 0038
Quillota

Germany
Local Institution - 0107
Essen

Germany
Local Institution
Freiburg

Germany
Local Institution - 0093
Grosshansdorf

Germany
KRH Klinikum Siloah-Oststadt-Heidehaus-Pneumology
Hannover

Germany
Local Institution - 0110
Heidelberg

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

Germany
Local Institution - 0119
Stuttgart

Israel, Tel-Aviv
Local Institution - 0145
Tel Aviv

Israel
Local Institution - 0113
Haifa

Israel
Local Institution
Jerusalem

Israel
Local Institution - 0114
Petah Tikva

Israel
Local Institution
Ramat Gan

Italy
Local Institution - 0073
Catania

Italy
Local Institution
Modena

Italy
Local Institution
Monza (MB)

Italy
Local Institution
Roma

Japan, Aichi
Local Institution - 0155
Seto

Japan, Fukushima
Local Institution - 0106
Koriyama

Japan, Hokkaido
Local Institution - 0180
Sapporo

Japan, Hyogo
Local Institution - 0095
Kobe

Japan, Hyogo
Local Institution - 0169
Kobe

Japan, Kanagawa
Local Institution - 0071
Yokohama

Japan, Osaka
Local Institution - 0112
Sakai

Japan, Shimane
Local Institution - 0128
Izumo

Japan, Shizuoka
Local Institution - 0064
Hamamatasu

Japan, Tokyo
Local Institution - 0080
Bunkyo-ku

Japan, Tokyo
Local Institution - 0153
Minato-ku

Japan, Tokyo
Local Institution - 0177
Shinjyuku-ku

Japan
Local Institution - 0117
Kumamoto

Japan
Local Institution - 0146
Nagasaki

Japan
Local Institution - 0170
Saitama

Japan
Local Institution - 0173
Tokyo

Korea, Republic of
Local Institution - 0087
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Nuevo Leon
Local Institution - 0109
Monterrey, N.l.

Mexico, Nuevo LEON
Local Institution - 0081
Monterrey

Mexico, Nuevo LEON
Local Institution - 0083
San Nicolas de los Garza

Mexico
Local Institution - 0156
Oaxaca

Spain
Local Institution
Barcelona

Spain
Local Institution - 0116
Barcelona

Spain
Local Institution - 0140
L'Hospitalet de Llobregat

Spain
Local Institution
Madrid

Spain
Local Institution - 0137
Madrid

Spain
Local Institution
Marbella Málaga

Spain
Local Institution - 0039
Pozuelo de Alarcon

Spain
Local Institution - 0147
Santander

Taiwan
Local Institution - 0176
Kaohsiung

Taiwan
Local Institution - 0174
Taipei

Taiwan
Local Institution - 0175
Taipei

United Kingdom
Local Institution - 0050
Cambridge

United Kingdom
Local Institution
Edinburgh

United Kingdom
Local Institution - 0041
London

United Kingdom
Local Institution - 0092
London

United Kingdom
Local Institution
London

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information