A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
NCT ID: NCT04308681
Last Updated: 2025-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
403 participants
INTERVENTIONAL
2020-07-29
2023-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IPF Dose 1 + Post Treatment Follow-up or OTE
IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
BMS-986278
Specified Dose on Specified Days
IPF Dose 2 + Post Treatment Follow-up or OTE
BMS-986278
Specified Dose on Specified Days
IPF Placebo + Post Treatment Follow-up or OTE
BMS-986278 Placebo
Specified Dose on Specified Days
PF-ILD Dose 1 + Post Treatment Follow-up or OTE
PF-ILD (Progressive Fibrotic Interstitial Lung Disease)
BMS-986278
Specified Dose on Specified Days
PF-ILD Dose 2 + Post Treatment Follow-up or OTE
BMS-986278
Specified Dose on Specified Days
PF-ILD Placebo + Post Treatment Follow-up or OTE
BMS-986278 Placebo
Specified Dose on Specified Days
Interventions
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BMS-986278 Placebo
Specified Dose on Specified Days
BMS-986278
Specified Dose on Specified Days
Eligibility Criteria
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Inclusion Criteria
* 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
* Active Smokers
* Current malignancy or previous malignancy up to 5 years prior to screening
* History of allergy to BMS-986278 or related compounds
21 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0032
Birmingham, Alabama, United States
Local Institution
Phoenix, Arizona, United States
Local Institution - 0028
Los Angeles, California, United States
Local Institution - 0043
Stanford, California, United States
University of Colorado Anschutz Medical Campus-Department of Medicine
Aurora, Colorado, United States
Local Institution - 0006
Denver, Colorado, United States
Local Institution - 0171
New Haven, Connecticut, United States
Local Institution - 0035
Gainesville, Florida, United States
Local Institution - 0166
Orlando, Florida, United States
Local Institution - 0078
Atlanta, Georgia, United States
Local Institution - 0031
Kansas City, Kansas, United States
Local Institution - 0154
Baltimore, Maryland, United States
Local Institution - 0003
Boston, Massachusetts, United States
Local Institution - 0030
Chesterfield, Missouri, United States
Local Institution - 0036
St Louis, Missouri, United States
Local Institution - 0029
Cincinnati, Ohio, United States
Local Institution - 0164
Columbus, Ohio, United States
Local Institution
Hershey, Pennsylvania, United States
Local Institution
Nashville, Tennessee, United States
Local Institution - 0096
Charlottesville, Virginia, United States
Local Institution
Falls Church, Virginia, United States
Local Institution - 0049
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0103
Rosario, Santa Fe Province, Argentina
Local Institution - 0097
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0115
Buenos Aires, , Argentina
Local Institution - 0048
Buenos Aires, , Argentina
Local Institution - 0122
Mendoza, , Argentina
Local Institution - 0045
Camperdown, New South Wales, Australia
Local Institution - 0025
Westmead, New South Wales, Australia
Local Institution - 0026
Brisbane, Queensland, Australia
Local Institution - 0046
Greenslopes, Queensland, Australia
Local Institution - 0022
Adelaide, South Australia, Australia
Local Institution - 0023
Heidelberg, Victoria, Australia
Local Institution - 0021
Murdoch, Western Australia, Australia
Local Institution - 0044
Nedlands, Western Australia, Australia
Local Institution - 0074
Brussels, , Belgium
Local Institution - 0065
Leuven, , Belgium
Local Institution - 0051
Liège, , Belgium
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution - 0076
São Paulo, , Brazil
Local Institution - 0141
Vancouver, British Columbia, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution - 0134
Toronto, Ontario, Canada
Local Institution - 0094
Montreal, Quebec, Canada
Local Institution - 0127
Québec, Quebec, Canada
Local Institution - 0144
Sherbrooke, Quebec, Canada
Local Institution - 0108
Curicó, Maule Region, Chile
Local Institution - 0054
Talca, Maule Region, Chile
Local Institution - 0038
Quillota, Región de Valparaíso, Chile
Local Institution - 0187
Beijing, Beijing Municipality, China
Local Institution - 0183
Beijing, Beijing Municipality, China
Local Institution - 0188
Wuhan, Hubei, China
Local Institution - 0189
Shanghai, Shanghai Municipality, China
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, , France
Local Institution - 0111
Hanover, Lower Saxony, Germany
Local Institution - 0107
Essen, , Germany
Local Institution
Freiburg im Breisgau, , Germany
Local Institution - 0093
Großhansdorf, , Germany
Local Institution - 0110
Heidelberg, , Germany
Local Institution - 0121
Munich, , Germany
Local Institution - 0119
Stuttgart, , Germany
Local Institution - 0145
Tel Aviv, Tel Aviv, Israel
Local Institution - 0113
Haifa, , Israel
Local Institution - 0149
Jerusalem, , Israel
Local Institution - 0114
Petah Tikva, , Israel
Local Institution - 0148
Ramat Gan, , Israel
Local Institution - 0073
Catania, , Italy
Local Institution - 0077
Modena, , Italy
Local Institution - 0089
Monza, , Italy
Local Institution - 0072
Roma, , Italy
Local Institution - 0155
Seto, Aichi-ken, Japan
Local Institution - 0106
Kōriyama, Fukushima, Japan
Local Institution - 0180
Sapporo, Hokkaido, Japan
Local Institution - 0095
Kobe, Hyōgo, Japan
Local Institution - 0169
Kobe, Hyōgo, Japan
Local Institution - 0071
Yokohama, Kanagawa, Japan
Local Institution - 0112
Sakai, Osaka, Japan
Local Institution - 0128
Izumo, Shimane, Japan
Local Institution - 0064
Hamamatasu, Shizuoka, Japan
Local Institution - 0080
Bunkyo-ku, Tokyo, Japan
Local Institution - 0153
Minato-ku, Tokyo, Japan
Local Institution - 0177
Shinjyuku-ku, Tokyo, Japan
Local Institution - 0117
Kumamoto, , Japan
Local Institution - 0146
Nagasaki, , Japan
Local Institution - 0170
Saitama, , Japan
Local Institution - 0173
Tokyo, , Japan
Local Institution
Mexico City, Mexico City, Mexico
Local Institution - 0081
Monterrey, Nuevo León, Mexico
Local Institution - 0109
Monterrey, N.l., Nuevo León, Mexico
Local Institution - 0083
San Nicolás de los Garza, Nuevo León, Mexico
Local Institution - 0156
Oaxaca City, Oaxaca, Mexico
Local Institution - 0087
Seoul, , South Korea
Local Institution - 0086
Seoul, , South Korea
Local Institution
Seoul, , South Korea
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 Alarcón, , Spain
Local Institution - 0147
Santander, , Spain
Local Institution - 0176
Kaohsiung City, , Taiwan
Local Institution - 0174
Taipei, , Taiwan
Local Institution - 0175
Taipei, , Taiwan
Local Institution - 0050
Cambridge, , United Kingdom
Local Institution - 0163
Edinburgh, , United Kingdom
Local Institution - 0041
London, , United Kingdom
Local Institution - 0092
London, , United Kingdom
Local Institution
London, , United Kingdom
Countries
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References
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Kreuter M, Maher TM, Wuyts WA, Valenzuela C, Hamblin M, Kim S, Patel A, Elpers B, Richeldi L. Effect of Admilparant, a Lysophosphatidic Acid Receptor 1 Antagonist, on Disease Progression in Pulmonary Fibrosis. Chest. 2025 Sep;168(3):677-687. doi: 10.1016/j.chest.2025.04.003. Epub 2025 Apr 8.
Corte TJ, Behr J, Cottin V, Glassberg MK, Kreuter M, Martinez FJ, Ogura T, Suda T, Wijsenbeek M, Berkowitz E, Elpers B, Kim S, Watanabe H, Fischer A, Maher TM. Efficacy and Safety of Admilparant, an LPA1 Antagonist, in Pulmonary Fibrosis: A Phase 2 Randomized Clinical Trial. Am J Respir Crit Care Med. 2025 Feb;211(2):230-238. doi: 10.1164/rccm.202405-0977OC.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2019-003992-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM027-040
Identifier Type: -
Identifier Source: org_study_id
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