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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Fibrosis
• Intervention / Treatment: Drug: BMS-986278; Other: BMS-986278 Placebo

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos AIres, Argentina, 1056
    • Local Institution - 0115
  • Buenos Aires, Argentina, 1638
    • Local Institution - 0048
  • Mendoza, Argentina, 5500
    • Local Institution - 0122
  • Distrito Federal
    • Buenos Aires, Distrito Federal, Argentina, 1425
      • Local Institution - 0049
  • Santa FE
    • Rosario, Santa FE, Argentina, S2000DTC
      • Local Institution - 0103
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000IAR
      • Local Institution - 0097
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Local Institution - 0045
    • Westmead, New South Wales, Australia, 2145
      • Local Institution - 0025
  • Queensland
    • Brisbane, Queensland, Australia, 4032
      • Local Institution - 0026
    • Greenslopes, Queensland, Australia, 4120
      • Local Institution - 0046
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 0022
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Local Institution - 0023
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Local Institution - 0021
    • Nedlands, Western Australia, Australia, 6009
      • Local Institution - 0044
• Belgium
  • Brussels, Belgium, 1200
    • Local Institution - 0074
  • Leuven, Belgium, 3000
    • Local Institution - 0065
  • Liège, Belgium, 4000
    • Local Institution - 0051
• Brazil
  • Sao Paulo, Brazil, 01323020
    • Local Institution - 0076
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
      • Local Institution
  • SAO Paulo
    • São Paulo, SAO Paulo, Brazil, 04266-010
      • Local Institution
    • São Paulo, SAO Paulo, Brazil, 04520-013
      • Local Institution
• Canada
  • Quebec, Canada, G1V 2G5
    • Local Institution - 0127
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Local Institution
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Local Institution - 0141
  • Ontario
    • Toronto, Ontario, Canada, M5T 3A9
      • Local Institution - 0134
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Local Institution - 0094
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Local Institution - 0144
• Chile
  • Maule
    • Curicó, Maule, Chile, 3341643
      • Local Institution - 0108
    • Talca, Maule, Chile
      • Local Institution - 0054
  • Valparaiso
    • Quillota, Valparaiso, Chile
      • Local Institution - 0038
• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Local Institution - 0187
    • Beijing, Beijing, China, 100730
      • Local Institution - 0183
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution - 0188
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Local Institution - 0189
• France
  • Bobigny, France, 93000
    • Local Institution - 0120
  • Bron, France, 69677
    • Local Institution - 0066
  • Dijon, France, 21000
    • Local Institution - 0136
  • Marseille, France, 13915
    • Local Institution - 0162
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75018
    • Local Institution - 0143
  • Rennes, France, 35033
    • Local Institution - 0067
  • Toulouse, France, 31059
    • Local Institution - 0132
• Germany
  • Essen, Germany, 45239
    • Local Institution - 0107
  • Freiburg, Germany, 79106
    • Local Institution
  • Grosshansdorf, Germany, 22927
    • Local Institution - 0093
  • Heidelberg, Germany, 69126
    • Local Institution - 0110
  • Munich, Germany, 81377
    • Local Institution - 0121
  • Stuttgart, Germany, 70736
    • Local Institution - 0119
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30459
      • Local Institution - 0111
• Israel
  • Haifa, Israel, 34362
    • Local Institution - 0113
  • Jerusalem, Israel, 9112001
    • Local Institution - 0149
  • Petah Tikva, Israel, 4941492
    • Local Institution - 0114
  • Ramat Gan, Israel, 5265601
    • Local Institution
  • Tel Aviv, Israel, 6423906
    • Local Institution - 0145
• Italy
  • Catania, Italy, 95123
    • Local Institution - 0073
  • Modena, Italy, 41125
    • Local Institution - 0077
  • Monza, Italy, 20900
    • Local Institution - 0089
  • Roma, Italy, 00168
    • Local Institution - 0072
• Japan
  • Kumamoto, Japan, 861-4193
    • Local Institution - 0117
  • Nagasaki, Japan, 852-8102
    • Local Institution - 0146
  • Saitama, Japan, 330-8553
    • Local Institution - 0170
  • Tokyo, Japan, 143-8541
    • Local Institution - 0173
  • Aichi
    • Seto, Aichi, Japan, 489-8642
      • Local Institution - 0155
  • Fukushima
    • Koriyama, Fukushima, Japan, 963-0197
      • Local Institution - 0106
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Local Institution - 0180
  • Hyogo
    • Kobe, Hyogo, Japan, 6500047
      • Local Institution - 0095
    • Kobe, Hyogo, Japan, 653-0013
      • Local Institution - 0169
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0051
      • Local Institution - 0071
  • Osaka
    • Sakai, Osaka, Japan, 591-8555
      • Local Institution - 0112
  • Shimane
    • Izumo, Shimane, Japan, 693-0021
      • Local Institution - 0128
  • Shizuoka
    • Hamamatasu, Shizuoka, Japan, 431-3192
      • Local Institution - 0064
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8510
      • Local Institution - 0080
    • Minato-ku, Tokyo, Japan, 1058470
      • Local Institution - 0153
    • Shinjyuku-ku, Tokyo, Japan, 162-8655
      • Local Institution - 0177
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Local Institution - 0087
  • Seoul, Korea, Republic of, 05505
    • Local Institution - 0086
  • Seoul, Korea, Republic of, 06355
    • Local Institution
• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06700
      • Local Institution
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64718
      • Local Institution - 0081
    • San Nicolas de los Garza, Nuevo LEON, Mexico, 66465
      • Local Institution - 0083
  • Nuevo Leon
    • Monterrey, N.l., Nuevo Leon, Mexico, 64460
      • Local Institution - 0109
  • Oaxaca
    • Oaxaca de Juarez, Oaxaca, Mexico, 68020
      • Local Institution - 0156
• Spain
  • Barcelona, Spain, 08035
    • Local Institution
  • Barcelona, Spain, 08036
    • Local Institution - 0116
  • L'Hospitalet de Llobregat, Spain, 08907
    • Local Institution - 0140
  • Madrid, Spain, 28034
    • Local Institution
  • Madrid, Spain, 28040
    • Local Institution - 0137
  • Marbella Málaga, Spain, 29603
    • Local Institution
  • Pozuelo de Alarcon, Spain, 28223
    • Local Institution - 0039
  • Santander, Spain, 39008
    • Local Institution - 0147
• Taiwan
  • Kaohsiung, Taiwan
    • Local Institution - 0176
  • Taipei, Taiwan, 10002
    • Local Institution - 0174
  • Taipei, Taiwan, 11217
    • Local Institution - 0175
• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Local Institution - 0050
  • Edinburgh, United Kingdom, EH16 4SA
    • Local Institution - 0163
  • London, United Kingdom, SE1 9RT
    • Local Institution - 0041
  • London, United Kingdom, SW3 6HP
    • Local Institution - 0092
  • London, United Kingdom, WC1E 6JF
    • Local Institution
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Local Institution - 0032
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Local Institution
  • California
    • Los Angeles, California, United States, 90024
      • Local Institution - 0028
    • Stanford, California, United States, 94305-528
      • Local Institution - 0043
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus-Department of Medicine
    • Denver, Colorado, United States, 80206
      • Local Institution - 0006
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Local Institution - 0171
  • Florida
    • Gainesville, Florida, United States, 32610
      • Local Institution - 0035
    • Orlando, Florida, United States, 32803
      • Central Florida Pulmonary Group-Research
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Local Institution - 0078
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Local Institution - 0031
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Local Institution - 0154
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Local Institution - 0003
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Local Institution - 0030
    • Saint Louis, Missouri, United States, 63110
      • Local Institution - 0036
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Local Institution - 0029
    • Columbus, Ohio, United States, 43221
      • Local Institution - 0164
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Local Institution
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Local Institution
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Local Institution - 0096
    • Falls Church, Virginia, United States, 22042
      • Local Institution

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants	Up to week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)		Up to 26 weeks
Incidence of Serious Adverse Events (SAEs)		Up to 26 weeks
Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment		Up to 26 weeks
Incidence of Treatment-Emergent Deaths		Up to 26 weeks
Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 26 weeks
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 26 weeks
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 26 weeks
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	PR interval: The time from the onset of the P wave to the start of the QRS complex	Up to 26 weeks
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval	QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization	Up to 26 weeks
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	QT interval: Measured from the beginning of the QRS complex to the end of the T wave	Up to 26 weeks
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval	QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)	Up to 26 weeks
Incidence of clinically significant changes in vital signs: Body temperature		Up to 26 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 26 weeks
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 26 weeks
Incidence of clinically significant changes in vital signs: Heart rate		Up to 26 weeks
Incidence of clinically significant changes in physical examination findings		Up to 26 weeks
Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants		Up to 26 weeks
Proportion of participants with ≥ 10% absolute decline in ppFVC (%)		At weeks 4, 8, 12, 16, 20, and 26
Proportion of participants with > 0% change in ppFVC		At weeks 4, 8, 12, 16, 20, and 26
Time to first acute exacerbation		Up to 26 weeks
Time to first ≥ 10% absolute decline in ppFVC (%)		Up to 26 weeks
Absolute change in FVC (mL) from baseline to Week 26		Up to 26 weeks
Absolute change in ppFVC (%) from baseline to Week 26		Up to 26 weeks
Absolute change in single-breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26		Up to 26 weeks
Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26		Up to 26 weeks
Change in walking endurance/distance from baseline at Week 26 as measured using the 6-Minute Walk Test (6MWT)		Up to 26 weeks
Proportion of participants with acute exacerbations of lung fibrosis		Up to 26 weeks
Maximum observed concentration (Cmax) of BMS-986278		Day 1 and Week 4
Time of maximum observed concentration (Tmax) of BMS-986278		Day 1 and Week 4
Area under the plasma concentration-time curve form time 0 to 8 hours post dose of BMS-986278 (AUC(0-8))		Day 1 and Week 4
Trough observed plasma concentration (Ctrough) of BMS-986278		Week 4 and Week 12

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Corte TJ, Lancaster L, Swigris JJ, Maher TM, Goldin JG, Palmer SM, Suda T, Ogura T, Minnich A, Zhan X, Tirucherai GS, Elpers B, Xiao H, Watanabe H, Smith RA, Charles ED, Fischer A. Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrotic interstitial lung disease (PF-ILD). BMJ Open Respir Res. 2021 Dec;8(1):e001026. doi: 10.1136/bmjresp-2021-001026.
• Cheng PTW, Kaltenbach RF 3rd, Zhang H, Shi J, Tao S, Li J, Kennedy LJ, Walker SJ, Shi Y, Wang Y, Dhanusu S, Reddigunta R, Kumaravel S, Jusuf S, Smith D, Krishnananthan S, Li J, Wang T, Heiry R, Sum CS, Kalinowski SS, Hung CP, Chu CH, Azzara AV, Ziegler M, Burns L, Zinker BA, Boehm S, Taylor J, Sapuppo J, Mosure K, Everlof G, Guarino V, Zhang L, Yang Y, Ruan Q, Xu C, Apedo A, Traeger SC, Cvijic ME, Lentz KA, Tirucherai G, Sivaraman L, Robl J, Ellsworth BA, Rosen G, Gordon DA, Soars MG, Gill M, Murphy BJ. Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA1) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases. J Med Chem. 2021 Nov 11;64(21):15549-15581. doi: 10.1021/acs.jmedchem.1c01256. Epub 2021 Oct 28.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: 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: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis
• Other Study ID Numbers: IM027-040; 2019-003992-21 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No