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): 403
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1638
    • Local Institution - 0048
  • Buenos Aires, Argentina, 1056
    • Local Institution - 0115
  • Mendoza, Argentina, 5500
    • Local Institution - 0122
  • Distrito Federal
    • Buenos Aires, Distrito Federal, Argentina, 1425
      • Local Institution - 0049
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000DTC
      • Local Institution - 0103
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, 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
  • São Paulo, Brazil, 01323020
    • Local Institution - 0076
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Local Institution
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04266-010
      • Local Institution
    • São Paulo, São Paulo, Brazil, 04520-013
      • Local Institution
• Canada
  • 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
    • Montreal, Quebec, Canada, H2X 3E4
      • Local Institution - 0094
    • Québec, Quebec, Canada, G1V 2G5
      • Local Institution - 0127
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Local Institution - 0144
• Chile
  • Maule Region
    • Curicó, Maule Region, Chile, 3341643
      • Local Institution - 0108
    • Talca, Maule Region, Chile, 3481349
      • Local Institution - 0054
  • Región de Valparaíso
    • Quillota, Región de Valparaíso, Chile
      • Local Institution - 0038
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100020
      • Local Institution - 0187
    • Beijing, Beijing Municipality, China, 100730
      • Local Institution - 0183
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution - 0188
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, 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
    • Hopital Europeen 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 im Breisgau, 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
  • Lower Saxony
    • Hanover, Lower Saxony, 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, 5262100
    • Local Institution - 0148
  • Tel Aviv
    • Tel Aviv, 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-ken
    • Seto, Aichi-ken, Japan, 489-8642
      • Local Institution - 0155
  • Fukushima
    • Kōriyama, Fukushima, Japan, 963-0197
      • Local Institution - 0106
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Local Institution - 0180
  • Hyōgo
    • Kobe, Hyōgo, Japan, 6500047
      • Local Institution - 0095
    • Kobe, Hyōgo, 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
• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • Local Institution
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64718
      • Local Institution - 0081
    • Monterrey, N.l., Nuevo León, Mexico, 64460
      • Local Institution - 0109
    • San Nicolás de los Garza, Nuevo León, Mexico, 66465
      • Local Institution - 0083
  • Oaxaca
    • Oaxaca City, Oaxaca, Mexico, 68020
      • Local Institution - 0156
• South Korea
  • Seoul, South Korea, 03722
    • Local Institution - 0087
  • Seoul, South Korea, 05505
    • Local Institution - 0086
  • Seoul, South Korea, 06355
    • Local Institution
• 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 Alarcón, Spain, 28223
    • Local Institution - 0039
  • Santander, Spain, 39008
    • Local Institution - 0147
• Taiwan
  • Kaohsiung City, 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
      • Local Institution - 0166
  • 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
    • St 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	Measure Description	Time Frame
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants	Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for the IPF cohort only as pre-specified in the protocol.	From baseline (first dose) up to week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants Experiencing Adverse Events (AEs)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.	From first dose up to 30 days after last dose during the main study treatment phase
The Number of Participants Experiencing Serious Adverse Events (SAEs)	A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.	From first dose up to 30 days after last dose during the main study treatment phase
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	The number of participants who discontinued study treatment due to adverse events (AEs)	From first dose up to 30 days after last dose during the main study treatment phase
The Number of Participants Who Died Due to Adverse Events (AEs)	The number of participants who died while receiving study treatment due to an adverse event	From first dose up to 30 days after last dose during the main study treatment phase
Maximum Concentration (Cmax)	Cmax is defined as the maximum concentration of the analyte recorded in the participants. Cmax of BMS-986278 and BMT-327319 was derived from plasma concentration versus time data.	On Day 1 and Week 4 (Day 29)
Time to Maximum Concentration (Tmax)	Tmax is defined as the amount of time until the maximum concentration of the analyte is recorded in the participants	On Day 1 and Week 4 (Day 29)
Area Under Curve (AUC0-8)	Area under the plasma concentration-time curve (AUC) from the timepoint of 0 hours to 24 hours post dose as measured on Day 1 and Week 4.	On Day 1 and Week 4 (Day 29)
Concentration Trough (Ctrough)	Ctrough is defined as the lowerst concentration of drug in the blood immediately before the next dose is administered	On Week 4 (Day 29) and Week 12 (Day 85)
The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities	A frequency summary of investigator clinical interpretation of ECG abnormal findings is listed.	At Week 26
Change From Baseline in Vital Sign Measurements	The change from baseline in select vital sign measurements. Baseline is defined as first dose.	At baseline and Week 26
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants	Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for PF-ILD cohort only as pre-specified in the protocol.	At baseline and Week 26
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%)	The number of participants with ≥ 10% absolute decline in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant. The number of participants represented signify the number of participants with applicable data during the specific visit at the specific timepoint.	At Weeks 4, 8, 12, 16, 20, and 26
The Number of Participants With 0% Change in ppFVC (%)	The number of participants with 0% change in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.	Weeks 4, 8, 12, 16, 20, and 26
Time to First Occurrence ≥ 10% Absolute Decline in ppFVC (%)	The amount of time in weeks to the participant's first occurrence ≥ 10% absolute decline in Percent Predicted Forced Vital Capacity (ppFVC). A participant's time is censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26. Kaplan-Meier product limit method will be employed to estimate the survival curves. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.	From first dose up to the first occurrence of ≥ 10% absolute decline in ppFVC
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC)	The absolute change in ppFVC (%) is measured from baseline up to the pre-specified timepoints of Weeks 4, 8, 12, 16, 20, and 26. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air (mL) exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.	From baseline up to Weeks 4, 8, 12, 16, 20, and 26
Absolute Change From Baseline in Forced Vital Capacity (FVC)	Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. The absolute change in FVC (mL) is measured from baseline up to Weeks 4, 8, 12, 16, 20, and 26.	From baseline up to Weeks 4, 8, 12, 16, 20, and 26
Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB)	The absolute change in single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.	From baseline up to Week 26
Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB)	The absolute change in percent predicted single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.	From baseline up to Week 26
Absolute Change From Baseline in Walking Endurance/Distance	The absolute change in walking endurance/distance as determined by the 6-minute walk test (6MWT) from baseline to Week 26. The 6-Minute Walk Test (6MWT) is a submaximal exercise test used to assess aerobic capacity and endurance. Baseline is defined as first dose.	From baseline up to Week 26
Time to First Acute Exacerbation	Time to first acute exacerbations of lung fibrosis was measured from the day of first dose up to the day of first acute exacerbation. Participants who discontinued the study treatment prior to the end of the main study without experiencing the event were excluded from the analysis. A participant's time was censored at the last observed time prior to discontinuation if a participant discontinued study without event, or at week 26 if a participant did not experience the event until the end of week 26. Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows: Acute worsening or development of dyspnea (< 1 month duration); Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia; Respiratory deterioration not fully explained by cardiac failure or fluid overload	From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
The Number of Participants Experiencing Acute Exacerbation	The number of participants experiencing acute exacerbations of lung fibrosis. Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows: Acute worsening or development of dyspnea (< 1 month duration); Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia; Respiratory deterioration not fully explained by cardiac failure or fluid overload	From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first

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.
• 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.

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): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

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; Fibrosis; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Idiopathic Interstitial Pneumonias
• 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