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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04308681
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Italy, Japan, Korea, Republic of, Mexico, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Fibrosis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: IPF Dose 1 + Post Treatment Follow-up or OTE

IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)

Experimental: IPF Dose 2 + Post Treatment Follow-up or OTE

Placebo Comparator: IPF Placebo + Post Treatment Follow-up or OTE

Experimental: PF-ILD Dose 1 + Post Treatment Follow-up or OTE

PF-ILD (Progressive Fibrotic Interstitial Lung Disease)

Experimental: PF-ILD Dose 2 + Post Treatment Follow-up or OTE

Placebo Comparator: PF-ILD Placebo + Post Treatment Follow-up or OTE

Interventions

Other: - BMS-986278 Placebo

Specified Dose on Specified Days

Drug: - BMS-986278

Specified Dose on Specified Days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Local Institution, Birmingham, Alabama

Status

Not yet recruiting

Address

Local Institution

Birmingham, Alabama, 35294

Site Contact

Site 0032

Clinical.Trials@bms.com

please email:

Local Institution, Los Angeles, California

Status

Not yet recruiting

Address

Local Institution

Los Angeles, California, 90048

Site Contact

Site 0069

Clinical.Trials@bms.com

please email:

Local Institution, Los Angeles, California

Status

Not yet recruiting

Address

Local Institution

Los Angeles, California, 90095

Site Contact

Site 0028

Clinical.Trials@bms.com

please email:

Local Institution, Sacramento, California

Status

Not yet recruiting

Address

Local Institution

Sacramento, California, 95817

Site Contact

Site 0063

Clinical.Trials@bms.com

please email:

Local Institution, Stanford, California

Status

Not yet recruiting

Address

Local Institution

Stanford, California, 94305

Site Contact

Site 0043

Clinical.Trials@bms.com

please email:

Local Institution, Aurora, Colorado

Status

Withdrawn

Address

Local Institution

Aurora, Colorado, 80045

Local Institution, Aurora, Colorado

Status

Not yet recruiting

Address

Local Institution

Aurora, Colorado, 80045

Site Contact

Site 0057

Clinical.Trials@bms.com

please email:

Local Institution, Denver, Colorado

Status

Not yet recruiting

Address

Local Institution

Denver, Colorado, 80206

Site Contact

Site 0006

Clinical.Trials@bms.com

please email:

Local Institution, Gainesville, Florida

Status

Not yet recruiting

Address

Local Institution

Gainesville, Florida, 32610

Site Contact

Site 0035

Clinical.Trials@bms.com

please email:

Local Institution, Gainesville, Florida

Status

Withdrawn

Address

Local Institution

Gainesville, Florida, 32611

Local Institution, Austell, Georgia

Status

Not yet recruiting

Address

Local Institution

Austell, Georgia, 30106

Site Contact

Site 0078

Clinical.Trials@bms.com

please email:

Local Institution, Chicago, Illinois

Status

Not yet recruiting

Address

Local Institution

Chicago, Illinois, 60637

Site Contact

Site 0058

Clinical.Trials@bms.com

please email:

Local Institution, Kansas City, Kansas

Status

Not yet recruiting

Address

Local Institution

Kansas City, Kansas, 66103

Site Contact

Site 0031

Clinical.Trials@bms.com

please email:

Local Institution, Kansas City, Kansas

Status

Withdrawn

Address

Local Institution

Kansas City, Kansas, 66160

Local Institution, Boston, Massachusetts

Status

Not yet recruiting

Address

Local Institution

Boston, Massachusetts, 02135

Site Contact

Site 0003

Clinical.Trials@bms.com

please email:

Local Institution, Chesterfield, Missouri

Status

Withdrawn

Address

Local Institution

Chesterfield, Missouri, 63017

Local Institution, Chesterfield, Missouri

Status

Not yet recruiting

Address

Local Institution

Chesterfield, Missouri, 63017

Site Contact

Site 0030

Clinical.Trials@bms.com

please email:

Local Institution, Saint Louis, Missouri

Status

Withdrawn

Address

Local Institution

Saint Louis, Missouri, 63110

Local Institution, Saint Louis, Missouri

Status

Not yet recruiting

Address

Local Institution

Saint Louis, Missouri, 63110

Site Contact

Site 0036

Clinical.Trials@bms.com

please email:

Local Institution, Durham, North Carolina

Status

Not yet recruiting

Address

Local Institution

Durham, North Carolina, 27710

Site Contact

Site 0091

Clinical.Trials@bms.com

please email:

Local Institution, Cincinnati, Ohio

Status

Withdrawn

Address

Local Institution

Cincinnati, Ohio, 45219

Local Institution, Cincinnati, Ohio

Status

Not yet recruiting

Address

Local Institution

Cincinnati, Ohio, 45267

Site Contact

Site 0029

Clinical.Trials@bms.com

please email:

Local Institution, Cleveland, Ohio

Status

Not yet recruiting

Address

Local Institution

Cleveland, Ohio, 44195

Site Contact

Site 0061

Clinical.Trials@bms.com

please email:

Local Institution, Hershey, Pennsylvania

Status

Not yet recruiting

Address

Local Institution

Hershey, Pennsylvania, 17033

Site Contact

Site 0027

Clinical.Trials@bms.com

please email:

Local Institution, Pittsburgh, Pennsylvania

Status

Not yet recruiting

Address

Local Institution

Pittsburgh, Pennsylvania, 15213

Site Contact

Site 0129

Clinical.Trials@bms.com

please email:

Local Institution, Providence, Rhode Island

Status

Not yet recruiting

Address

Local Institution

Providence, Rhode Island, 02903

Site Contact

Site 0037

Clinical.Trials@bms.com

please email:

Local Institution, Charleston, South Carolina

Status

Not yet recruiting

Address

Local Institution

Charleston, South Carolina, 29425

Site Contact

Site 0062

Clinical.Trials@bms.com

please email:

Local Institution, Nashville, Tennessee

Status

Not yet recruiting

Address

Local Institution

Nashville, Tennessee, 37232

Site Contact

Site 0033

Clinical.Trials@bms.com

please email:

Local Institution, Salt Lake City, Utah

Status

Not yet recruiting

Address

Local Institution

Salt Lake City, Utah, 84108

Site Contact

Site 0068

Clinical.Trials@bms.com

please email:

Local Institution, Charlottesville, Virginia

Status

Not yet recruiting

Address

Local Institution

Charlottesville, Virginia, 22908

Site Contact

Site 0096

Clinical.Trials@bms.com

please email:

Local Institution, Falls Church, Virginia

Status

Not yet recruiting

Address

Local Institution

Falls Church, Virginia, 22042

Site Contact

Site 0088

Clinical.Trials@bms.com

please email:

Local Institution, Madison, Wisconsin

Status

Not yet recruiting

Address

Local Institution

Madison, Wisconsin, 53792-9988

Site Contact

Site 0059

Clinical.Trials@bms.com

please email:

International Sites

Local Institution, Florida, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Local Institution

Florida, Buenos Aires,

Site Contact

Site 0048

Clinical.Trials@bms.com

please email:

Local Institution, Caba, Distrito Federal, Argentina

Status

Not yet recruiting

Address

Local Institution

Caba, Distrito Federal, C1425FVH

Site Contact

Site 0049

Clinical.Trials@bms.com

please email:

Local Institution, City, Mendoza, Argentina

Status

Not yet recruiting

Address

Local Institution

City, Mendoza, 5500

Site Contact

Site 0122

Clinical.Trials@bms.com

please email:

Local Institution, Rosario, Santa FE, Argentina

Status

Not yet recruiting

Address

Local Institution

Rosario, Santa FE, S2000

Site Contact

Site 0103

Clinical.Trials@bms.com

please email:

Local Institution, San Miguel de Tucuman, Tucuman, Argentina

Status

Not yet recruiting

Address

Local Institution

San Miguel de Tucuman, Tucuman, T4000IAR

Site Contact

Site 0097

Clinical.Trials@bms.com

please email:

Local Institution, Buenos AIres, Argentina

Status

Not yet recruiting

Address

Local Institution

Buenos AIres, , 1056

Site Contact

Site 0115

Clinical.Trials@bms.com

please email:

Local Institution, Camperdown, New South Wales, Australia

Status

Not yet recruiting

Address

Local Institution

Camperdown, New South Wales, 2050

Site Contact

Site 0045

Clinical.Trials@bms.com

please email:

Local Institution, Westmead, New South Wales, Australia

Status

Not yet recruiting

Address

Local Institution

Westmead, New South Wales, 2145

Site Contact

Site 0025

Clinical.Trials@bms.com

please email:

Local Institution, Brisbane, Queensland, Australia

Status

Not yet recruiting

Address

Local Institution

Brisbane, Queensland, 4032

Site Contact

Site 0026

Clinical.Trials@bms.com

please email:

Local Institution, Greenslopes, Queensland, Australia

Status

Recruiting

Address

Local Institution

Greenslopes, Queensland, 4120

Site Contact

Site 0046

Clinical.Trials@bms.com

please email:

Local Institution, Adelaide, South Australia, Australia

Status

Not yet recruiting

Address

Local Institution

Adelaide, South Australia, 5000

Site Contact

Site 0022

Clinical.Trials@bms.com

please email:

Local Institution, Heidelberg, Victoria, Australia

Status

Not yet recruiting

Address

Local Institution

Heidelberg, Victoria, 3084

Site Contact

Site 0023

Clinical.Trials@bms.com

please email:

Local Institution, Murdoch, Western Australia, Australia

Status

Recruiting

Address

Local Institution

Murdoch, Western Australia, 6150

Site Contact

Site 0021

Clinical.Trials@bms.com

please email:

Local Institution, Nedlands, Western Australia, Australia

Status

Withdrawn

Address

Local Institution

Nedlands, Western Australia, 6009

Local Institution, Nedlands, Western Australia, Australia

Status

Recruiting

Address

Local Institution

Nedlands, Western Australia, 6009

Site Contact

Site 0044

Clinical.Trials@bms.com

please email:

Local Institution, Bruxelles, Belgium

Status

Not yet recruiting

Address

Local Institution

Bruxelles, , 1200

Site Contact

Site 0074

Clinical.Trials@bms.com

please email:

Local Institution, LEuven, Belgium

Status

Recruiting

Address

Local Institution

LEuven, , 3000

Site Contact

Site 0065

Clinical.Trials@bms.com

please email:

Local Institution, Liege, Belgium

Status

Not yet recruiting

Address

Local Institution

Liege, , 4000

Site Contact

Site 0051

Clinical.Trials@bms.com

please email:

Local Institution, Porto Alegre, RIO Grande DO SUL, Brazil

Status

Not yet recruiting

Address

Local Institution

Porto Alegre, RIO Grande DO SUL, 91350-200

Site Contact

Site 0056

Clinical.Trials@bms.com

please email:

Local Institution, S?o Paulo, SAO Paulo, Brazil

Status

Not yet recruiting

Address

Local Institution

S?o Paulo, SAO Paulo, 01323-903

Site Contact

Site 0076

Clinical.Trials@bms.com

please email:

Local Institution, S?o Paulo, SAO Paulo, Brazil

Status

Not yet recruiting

Address

Local Institution

S?o Paulo, SAO Paulo, 04266-010

Site Contact

Site 0055

Clinical.Trials@bms.com

please email:

Local Institution, S?o Paulo, SAO Paulo, Brazil

Status

Not yet recruiting

Address

Local Institution

S?o Paulo, SAO Paulo, 04520-013

Site Contact

Site 0079

Clinical.Trials@bms.com

please email:

Local Institution, Montreal, Quebec, Canada

Status

Not yet recruiting

Address

Local Institution

Montreal, Quebec, H2X 0C1

Site Contact

Site 0094

Clinical.Trials@bms.com

please email:

Local Institution, Sherbrooke, Quebec, Canada

Status

Not yet recruiting

Address

Local Institution

Sherbrooke, Quebec, JiH 5N4

Site Contact

Site 0144

Clinical.Trials@bms.com

please email:

Local Institution, Curico, Maule, Chile

Status

Not yet recruiting

Address

Local Institution

Curico, Maule, 3440000

Site Contact

Site 0108

Clinical.Trials@bms.com

please email:

Local Institution, Talca, Maule, Chile

Status

Not yet recruiting

Address

Local Institution

Talca, Maule,

Site Contact

Site 0054

Clinical.Trials@bms.com

please email:

Local Institution, Quillota, Valparaiso, Chile

Status

Not yet recruiting

Address

Local Institution

Quillota, Valparaiso, 2260000

Site Contact

Site 0038

Clinical.Trials@bms.com

please email:

Local Institution, Bobigny, France

Status

Not yet recruiting

Address

Local Institution

Bobigny, , 93000

Site Contact

Site 0120

Clinical.Trials@bms.com

please email:

Local Institution, Bron, France

Status

Not yet recruiting

Address

Local Institution

Bron, , 69677

Site Contact

Site 0066

Clinical.Trials@bms.com

please email:

Local Institution, Dijon, France

Status

Not yet recruiting

Address

Local Institution

Dijon, , 21079

Site Contact

Site 0136

Clinical.Trials@bms.com

please email:

Local Institution, Paris, France

Status

Not yet recruiting

Address

Local Institution

Paris, , 75015

Site Contact

Site 0151

Clinical.Trials@bms.com

please email:

Local Institution, Paris, France

Status

Not yet recruiting

Address

Local Institution

Paris, , 75018

Site Contact

Site 0143

Clinical.Trials@bms.com

please email:

Local Institution, Rennes, France

Status

Not yet recruiting

Address

Local Institution

Rennes, , 35033

Site Contact

Site 0067

Clinical.Trials@bms.com

please email:

Local Institution, Toulouse, France

Status

Not yet recruiting

Address

Local Institution

Toulouse, , 31059

Site Contact

Site 0132

Clinical.Trials@bms.com

please email:

Local Institution, Essen, Germany

Status

Not yet recruiting

Address

Local Institution

Essen, , 45239

Site Contact

Site 0107

Clinical.Trials@bms.com

please email:

Local Institution, Freiburg, Germany

Status

Not yet recruiting

Address

Local Institution

Freiburg, , 79106

Site Contact

Site 0118

Clinical.Trials@bms.com

please email:

Local Institution, Gerlingen, Germany

Status

Not yet recruiting

Address

Local Institution

Gerlingen, , 70839

Site Contact

Site 0119

Clinical.Trials@bms.com

please email:

Local Institution, Grosshandorf, Germany

Status

Not yet recruiting

Address

Local Institution

Grosshandorf, , 22927

Site Contact

Site 0093

Clinical.Trials@bms.com

please email:

Local Institution, Hannover, Germany

Status

Recruiting

Address

Local Institution

Hannover, , 30459

Site Contact

Site 0111

Clinical.Trials@bms.com

please email:

Local Institution, Heidelberg, Germany

Status

Not yet recruiting

Address

Local Institution

Heidelberg, , 69126

Site Contact

Site 0110

Clinical.Trials@bms.com

please email:

Local Institution, Munich, Germany

Status

Not yet recruiting

Address

Local Institution

Munich, , 81377

Site Contact

Site 0121

Clinical.Trials@bms.com

please email:

Local Institution, Catania, Italy

Status

Not yet recruiting

Address

Local Institution

Catania, , 95123

Site Contact

Site 0073

Clinical.Trials@bms.com

please email:

Local Institution, Modena, Italy

Status

Not yet recruiting

Address

Local Institution

Modena, , 41124

Site Contact

Site 0077

Clinical.Trials@bms.com

please email:

Local Institution, Monza (MB), Italy

Status

Not yet recruiting

Address

Local Institution

Monza (MB), , 20900

Site Contact

Site 0089

Clinical.Trials@bms.com

please email:

Local Institution, Roma, Italy

Status

Not yet recruiting

Address

Local Institution

Roma, , 00168

Site Contact

Site 0072

Clinical.Trials@bms.com

please email:

Local Institution, Koriyama, Fukushima, Japan

Status

Recruiting

Address

Local Institution

Koriyama, Fukushima, 963-0197

Site Contact

Site 0106

Clinical.Trials@bms.com

please email:

Local Institution, Kobe, Hyogo, Japan

Status

Recruiting

Address

Local Institution

Kobe, Hyogo, 6500047

Site Contact

Site 0095

Clinical.Trials@bms.com

please email:

Local Institution, Yokohama-Shi, Kanagawa, Japan

Status

Recruiting

Address

Local Institution

Yokohama-Shi, Kanagawa, 2360051

Site Contact

Site 0071

Clinical.Trials@bms.com

please email:

Local Institution, Sakai, Osaka, Japan

Status

Recruiting

Address

Local Institution

Sakai, Osaka, 591-8555

Site Contact

Site 0112

Clinical.Trials@bms.com

please email:

Local Institution, Izumo, Shimane, Japan

Status

Not yet recruiting

Address

Local Institution

Izumo, Shimane, 6938501

Site Contact

Site 0128

Clinical.Trials@bms.com

please email:

Local Institution, Hamamatasu, Shizuoka, Japan

Status

Not yet recruiting

Address

Local Institution

Hamamatasu, Shizuoka, 431-3192

Site Contact

Site 0064

Clinical.Trials@bms.com

please email:

Local Institution, Bunkyo-ku, Tokyo, Japan

Status

Recruiting

Address

Local Institution

Bunkyo-ku, Tokyo, 113-8510

Site Contact

Site 0080

Clinical.Trials@bms.com

please email:

Local Institution, Kumamoto, Japan

Status

Not yet recruiting

Address

Local Institution

Kumamoto, , 861-4193

Site Contact

Site 0117

Clinical.Trials@bms.com

please email:

Local Institution, Nagasaki, Japan

Status

Not yet recruiting

Address

Local Institution

Nagasaki, , 8528501

Site Contact

Site 0146

Clinical.Trials@bms.com

please email:

Local Institution, Seoul, Korea, Republic of

Status

Recruiting

Address

Local Institution

Seoul, , 03722

Site Contact

Site 0087

Clinical.Trials@bms.com

please email:

Local Institution, Seoul, Korea, Republic of

Status

Recruiting

Address

Local Institution

Seoul, , 05505

Site Contact

Site 0086

Clinical.Trials@bms.com

please email:

Local Institution, Seoul, Korea, Republic of

Status

Recruiting

Address

Local Institution

Seoul, , 06355

Site Contact

Site 0085

Clinical.Trials@bms.com

please email:

Local Institution, Cdmx, Distrito Federal, Mexico

Status

Not yet recruiting

Address

Local Institution

Cdmx, Distrito Federal, 14080

Site Contact

Site 0082

Clinical.Trials@bms.com

please email:

Local Institution, Monterrey, Nuevo LEON, Nuevo LEON, Mexico

Status

Not yet recruiting

Address

Local Institution

Monterrey, Nuevo LEON, Nuevo LEON, 64718

Site Contact

Site 0081

Clinical.Trials@bms.com

please email:

Local Institution, Monterrey, Nuevo LEON, Mexico

Status

Not yet recruiting

Address

Local Institution

Monterrey, Nuevo LEON, 64460

Site Contact

Site 0109

Clinical.Trials@bms.com

please email:

Local Institution, San Nicolas de Los Garza, Nuevo LEON, Mexico

Status

Not yet recruiting

Address

Local Institution

San Nicolas de Los Garza, Nuevo LEON, 66465

Site Contact

Site 0083

Clinical.Trials@bms.com

please email:

Local Institution, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Local Institution

Cambridge, , CB2 0AY

Site Contact

Site 0050

Clinical.Trials@bms.com

please email:

Local Institution, Exeter, United Kingdom

Status

Not yet recruiting

Address

Local Institution

Exeter, , EX2 5DW

Site Contact

Site 0040

Clinical.Trials@bms.com

please email:

Local Institution, London, United Kingdom

Status

Not yet recruiting

Address

Local Institution

London, , SE19RT

Site Contact

Site 0041

Clinical.Trials@bms.com

please email:

Local Institution, London, United Kingdom

Status

Not yet recruiting

Address

Local Institution

London, , SW3 6NP

Site Contact

Site 0092

Clinical.Trials@bms.com

please email:

Local Institution, London, United Kingdom

Status

Not yet recruiting

Address

Local Institution

London, , WC1E 6JF

Site Contact

Site 0139

Clinical.Trials@bms.com

please email:

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The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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