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

NCT04308681 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM027-0402019-003992-21
• Study Type: interventional
• Target: 403
• Locations: 18 countries
• Sites: 119

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.

Conditions

Pulmonary Fibrosis

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• The Number of Participants Experiencing Adverse Events (AEs)

  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)

  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

  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)

  From first dose up to 30 days after last dose during the main study treatment phase

• Maximum Concentration (Cmax)

  On Day 1 and Week 4 (Day 29)

Study Arms (6)

IPF Dose 1 + Post Treatment Follow-up or OTE

EXPERIMENTAL

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

Drug: BMS-986278

IPF Dose 2 + Post Treatment Follow-up or OTE

EXPERIMENTAL

Drug: BMS-986278

IPF Placebo + Post Treatment Follow-up or OTE

PLACEBO COMPARATOR

Other: BMS-986278 Placebo

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

EXPERIMENTAL

PF-ILD (Progressive Fibrotic Interstitial Lung Disease)

Drug: BMS-986278

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

EXPERIMENTAL

Drug: BMS-986278

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

PLACEBO COMPARATOR

Other: BMS-986278 Placebo

Interventions

BMS-986278 Placebo OTHER

Specified Dose on Specified Days

IPF Placebo + Post Treatment Follow-up or OTE; PF-ILD Placebo + Post Treatment Follow-up or OTE

BMS-986278 DRUG

Specified Dose on Specified Days

IPF Dose 1 + Post Treatment Follow-up or OTE; IPF Dose 2 + Post Treatment Follow-up or OTE; PF-ILD Dose 1 + Post Treatment Follow-up or OTE; PF-ILD Dose 2 + Post Treatment Follow-up or OTE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (119)

Local Institution - 0032

Birmingham, Alabama, 35294, United States

Location

Local Institution

Phoenix, Arizona, 85006, United States

Location

Local Institution - 0028

Los Angeles, California, 90024, United States

Location

Local Institution - 0043

Stanford, California, 94305-528, United States

Location

University of Colorado Anschutz Medical Campus-Department of Medicine

Aurora, Colorado, 80045, United States

Location

Local Institution - 0006

Denver, Colorado, 80206, United States

Location

Local Institution - 0171

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0035

Gainesville, Florida, 32610, United States

Location

Local Institution - 0166

Orlando, Florida, 32803, United States

Location

Local Institution - 0078

Atlanta, Georgia, 30309, United States

Location

Local Institution - 0031

Kansas City, Kansas, 66160, United States

Location

Local Institution - 0154

Baltimore, Maryland, 21224, United States

Location

Local Institution - 0003

Boston, Massachusetts, 02135, United States

Location

Local Institution - 0030

Chesterfield, Missouri, 63017, United States

Location

Local Institution - 0036

St Louis, Missouri, 63110, United States

Location

Local Institution - 0029

Cincinnati, Ohio, 45267, United States

Location

Local Institution - 0164

Columbus, Ohio, 43221, United States

Location

Local Institution

Hershey, Pennsylvania, 17033, United States

Location

Local Institution

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0096

Charlottesville, Virginia, 22908, United States

Location

Local Institution

Falls Church, Virginia, 22042, United States

Location

Local Institution - 0049

Buenos Aires, Distrito Federal, 1425, Argentina

Location

Local Institution - 0103

Rosario, Santa Fe Province, S2000DTC, Argentina

Location

Local Institution - 0097

San Miguel de Tucumán, Tucumán Province, T4000IAR, Argentina

Location

Local Institution - 0115

Buenos Aires, 1056, Argentina

Location

Local Institution - 0048

Buenos Aires, 1638, Argentina

Location

Local Institution - 0122

Mendoza, 5500, Argentina

Location

Local Institution - 0045

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0025

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0026

Brisbane, Queensland, 4032, Australia

Location

Local Institution - 0046

Greenslopes, Queensland, 4120, Australia

Location

Local Institution - 0022

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0023

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0021

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0044

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0074

Brussels, 1200, Belgium

Location

Local Institution - 0065

Leuven, 3000, Belgium

Location

Local Institution - 0051

Liège, 4000, Belgium

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Local Institution

São Paulo, São Paulo, 04266-010, Brazil

Location

Local Institution

São Paulo, São Paulo, 04520-013, Brazil

Location

Local Institution - 0076

São Paulo, 01323020, Brazil

Location

Local Institution - 0141

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Local Institution

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Local Institution - 0134

Toronto, Ontario, M5T 3A9, Canada

Location

Local Institution - 0094

Montreal, Quebec, H2X 3E4, Canada

Location

Local Institution - 0127

Québec, Quebec, G1V 2G5, Canada

Location

Local Institution - 0144

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Local Institution - 0108

Curicó, Maule Region, 3341643, Chile

Location

Local Institution - 0054

Talca, Maule Region, 3481349, Chile

Location

Local Institution - 0038

Quillota, Región de Valparaíso, 0, Chile

Location

Local Institution - 0187

Beijing, Beijing Municipality, 100020, China

Location

Local Institution - 0183

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 0188

Wuhan, Hubei, 430022, China

Location

Local Institution - 0189

Shanghai, Shanghai Municipality, 200030, China

Location

Local Institution - 0120

Bobigny, 93000, France

Location

Local Institution - 0066

Bron, 69677, France

Location

Local Institution - 0136

Dijon, 21000, France

Location

Local Institution - 0162

Marseille, 13915, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Local Institution - 0143

Paris, 75018, France

Location

Local Institution - 0067

Rennes, 35033, France

Location

Local Institution - 0132

Toulouse, 31059, France

Location

Local Institution - 0111

Hanover, Lower Saxony, 30459, Germany

Location

Local Institution - 0107

Essen, 45239, Germany

Location

Local Institution

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 0093

Großhansdorf, 22927, Germany

Location

Local Institution - 0110

Heidelberg, 69126, Germany

Location

Local Institution - 0121

Munich, 81377, Germany

Location

Local Institution - 0119

Stuttgart, 70736, Germany

Location

Local Institution - 0145

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Local Institution - 0113

Haifa, 34362, Israel

Location

Local Institution - 0149

Jerusalem, 9112001, Israel

Location

Local Institution - 0114

Petah Tikva, 4941492, Israel

Location

Local Institution - 0148

Ramat Gan, 5262100, Israel

Location

Local Institution - 0073

Catania, 95123, Italy

Location

Local Institution - 0077

Modena, 41125, Italy

Location

Local Institution - 0089

Monza, 20900, Italy

Location

Local Institution - 0072

Roma, 00168, Italy

Location

Local Institution - 0155

Seto, Aichi-ken, 489-8642, Japan

Location

Local Institution - 0106

Kōriyama, Fukushima, 963-0197, Japan

Location

Local Institution - 0180

Sapporo, Hokkaido, 060-8543, Japan

Location

Local Institution - 0095

Kobe, Hyōgo, 6500047, Japan

Location

Local Institution - 0169

Kobe, Hyōgo, 653-0013, Japan

Location

Local Institution - 0071

Yokohama, Kanagawa, 236-0051, Japan

Location

Local Institution - 0112

Sakai, Osaka, 591-8555, Japan

Location

Local Institution - 0128

Izumo, Shimane, 693-0021, Japan

Location

Local Institution - 0064

Hamamatasu, Shizuoka, 431-3192, Japan

Location

Local Institution - 0080

Bunkyo-ku, Tokyo, 113-8510, Japan

Location

Local Institution - 0153

Minato-ku, Tokyo, 1058470, Japan

Location

Local Institution - 0177

Shinjyuku-ku, Tokyo, 162-8655, Japan

Location

Local Institution - 0117

Kumamoto, 861-4193, Japan

Location

Local Institution - 0146

Nagasaki, 852-8102, Japan

Location

Local Institution - 0170

Saitama, 330-8553, Japan

Location

Local Institution - 0173

Tokyo, 143-8541, Japan

Location

Local Institution

Mexico City, Mexico City, 06700, Mexico

Location

Local Institution - 0081

Monterrey, Nuevo León, 64718, Mexico

Location

Local Institution - 0109

Monterrey, N.l., Nuevo León, 64460, Mexico

Location

Local Institution - 0083

San Nicolás de los Garza, Nuevo León, 66465, Mexico

Location

Local Institution - 0156

Oaxaca City, Oaxaca, 68020, Mexico

Location

Local Institution - 0087

Seoul, 03722, South Korea

Location

Local Institution - 0086

Seoul, 05505, South Korea

Location

Local Institution

Seoul, 06355, South Korea

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution - 0116

Barcelona, 08036, Spain

Location

Local Institution - 0140

L'Hospitalet de Llobregat, 08907, Spain

Location

Local Institution

Madrid, 28034, Spain

Location

Local Institution - 0137

Madrid, 28040, Spain

Location

Local Institution

Marbella Málaga, 29603, Spain

Location

Local Institution - 0039

Pozuelo de Alarcón, 28223, Spain

Location

Local Institution - 0147

Santander, 39008, Spain

Location

Local Institution - 0176

Kaohsiung City, 0, Taiwan

Location

Local Institution - 0174

Taipei, 10002, Taiwan

Location

Local Institution - 0175

Taipei, 11217, Taiwan

Location

Local Institution - 0050

Cambridge, CB2 0AY, United Kingdom

Location

Local Institution - 0163

Edinburgh, EH16 4SA, United Kingdom

Location

Local Institution - 0041

London, SE1 9RT, United Kingdom

Location

Local Institution - 0092

London, SW3 6HP, United Kingdom

Location

Local Institution

London, WC1E 6JF, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 40210090 DERIVED

• 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.

  PMID: 39393084 DERIVED

• 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.

  PMID: 34969771 DERIVED

• 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.

  PMID: 34709814 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Idiopathic Interstitial Pneumonias; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: July 29, 2020
• Primary Completion: August 4, 2022
• Study Completion: September 22, 2023
• Last Updated: February 3, 2026
• Results First Posted: February 24, 2025

Record last verified: 2026-01

Locations

CL (3); US (21); TW (3); ME (5); AU (8); GB (5); CA (6); KR (3); ES (8); BR (4); DE (7); AR (6); CN (4); BE (3); FR (8); JP (16); IT (4); IL (5)