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Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis Phase 3 2,277

Not yet recruiting
Clinical Trial NCT07441408 is designed to study Treatment for Pulmonary Fibrosis. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on December 16, 2026 until the study accrues 2,277 participants. Led by Bristol-Myers Squibb, this study is expected to complete by March 30, 2030. The latest data from ClinicalTrials.gov was last updated on March 2, 2026.
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of Admilparant in participants who completed participation in parent studies IM027-068 (for idiopathic pulmonary fibrosis (IPF)) and IM027-1015 (for progressive pulmonary fibrosis (PPF)).
Official Title

An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis

Conditions
Pulmonary Fibrosis
Other Study IDs
  • IM027-1016
  • 2025-522373-10 (Other Identifier) (EU CTR)
  • U1111-1322-7787 (Other Identifier) (WHO)
NCT ID Number
Start Date (Actual)
2026-12-16
Last Update Posted
2026-03-02
Completion Date (Estimated)
2030-03-30
Enrollment (Estimated)
2,277
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
LPA1 receptor antagonist
Idiopathic pulmonary fibrosis
Progressive pulmonary fibrosis
Long-term extension
IPF
PPF
IM027068
IM0271015
Follow up
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBMS-986278 Arm
BMS-986278
Specified dose on specified days
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Week 100
Number of Participants With Serious Adverse Events (SAEs)
Up to Week 100
Number of Participants With AEs leading to Discontinuation
Up to Week 100
Number of Participants With AEs leading to Deaths
Up to Week 100
Number of Participants With Clinically Significant Laboraty Abnormalities
Up to Week 100
Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities
Up to Week 100
Number of Participants With Clinically Significant Vital Sign Abnormalities
Up to Week 100
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All

- Participants must have completed participation in either IM027068 or IM0271015 (defined as receiving study intervention (IMP) until completion of EOT visit).

  • Clinically significant AE that resulted in discontinuation or interruption of IMP (Investigational Medicinal Product) in IM027068 or IM0271015 without reinitiation of IMP.
  • Exhibit symptoms of heart failure at rest.
  • History of lung reduction surgery or lung transplant. Note: Being on the transplantation list is allowed.
  • Participants with known PAH (Pulmonary Arterial Hypertension) who has been on single drug therapy that now requires multi-drug therapy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Bristol-Myers Squibb logoBristol-Myers Squibb
Study Central Contact
Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
Contact: First line of the email MUST contain NCT # and Site #.
111 Study Locations in 16 Countries

Buenos Aires

Local Institution - 0013, Florida, Vicente López, Buenos Aires, 1602, Argentina
Site 0013, Contact
Local Institution - 0014, Mar del Plata, Buenos Aires, 7600, Argentina
Site 0014, Contact
Local Institution - 0007, Quilmes, Buenos Aires, 1878, Argentina
Site 0007, Contact
Local Institution - 0009, San Juan Bautista, Buenos Aires, 1888, Argentina
Site 0009, Contact

B

Local Institution - 0003, Mar del Plata, B, 7600, Argentina
Site 0003, Contact

Córdoba Province

Local Institution - 0001, Córdoba, Córdoba Province, X5003DCE, Argentina
Site 0001, Contact

Mendoza Province

Local Institution - 0002, Godoy Cruz, Mendoza Province, 5501, Argentina
Site 0002, Contact

M

Local Institution - 0011, Mendoza, M, 5500, Argentina
Site 0011, Contact

S

Local Institution - 0015, Rosario, S, 2000, Argentina
Site 0015, Contact
Local Institution - 0010, Buenos Aires, C1056ABI, Argentina
Site 0010, Contact
Local Institution - 0008, Santa Fe, 3000, Argentina
Site 0008, Contact

New South Wales

Local Institution - 0287, Camperdown, New South Wales, 2050, Australia
Site 0287, Contact

Queensland

Local Institution - 0290, Chermside, Queensland, 4032, Australia
Site 0290, Contact
Local Institution - 0291, Greenslopes, Queensland, 4120, Australia
Site 0291, Contact
Local Institution - 0293, South Brisbane, Queensland, 4101, Australia
Site 0293, Contact

South Australia

Local Institution - 0289, Adelaide, South Australia, 5000, Australia
Site 0289, Contact

Victoria

Local Institution - 0288, Frankston, Victoria, 3199, Australia
Site 0288, Contact

Western Australia

Local Institution - 0285, Murdoch, Western Australia, 6150, Australia
Site 0285, Contact
Local Institution - 0292, Nedlands, Western Australia, 6009, Australia
Site 0292, Contact
Local Institution - 0286, Melbourne, 3128, Australia
Site 0286, Contact
Local Institution - 0284, Wentworthville, NSW2145, Australia
Site 0284, Contact

Namur

Local Institution - 0249, Yvoir, Namur, 5530, Belgium
Site 0249, Contact

Vlaams-Brabant

Local Institution - 0252, Leuven, Vlaams-Brabant, 3000, Belgium
Site 0252, Contact
Local Institution - 0248, Brussels, 1200, Belgium
Site 0248, Contact
Local Institution - 0251, Kortrijk, 8500, Belgium
Site 0251, Contact
Local Institution - 0250, Liège, 4000, Belgium
Site 0250, Contact

Maule Region

Local Institution - 0051, Talca, Maule Region, 3466706, Chile
Site 0051, Contact

Región de Valparaíso

Local Institution - 0050, Quillota, Región de Valparaíso, 2260000, Chile
Site 0050, Contact

ANT

Local Institution - 0044, Medellín, ANT, 050021, Colombia
Site 0044, Contact
Local Institution - 0047, Medellín, ANT, 050034, Colombia
Site 0047, Contact

DC

Local Institution - 0043, Bogotá, DC, 110111, Colombia
Site 0043, Contact
Local Institution - 0046, Bogotá, DC, 110131, Colombia
Site 0046, Contact

Santander Department

Local Institution - 0041, Floridablanca, Santander Department, 681004, Colombia
Site 0041, Contact

VAC

Local Institution - 0040, Santiago de Cali, VAC, 760046, Colombia
Site 0040, Contact
Local Institution - 0039, Bogotá, 0, Colombia
Site 0039, Contact
Local Institution - 0048, Bogotá, Colombia
Site 0048, Contact
Local Institution - 0042, Manizales, 0, Colombia
Site 0042, Contact
Local Institution - 0045, Zipaquirá, 250252, Colombia
Site 0045, Contact

Capital Region

Local Institution - 0487, Hellerup, Capital Region, 2900, Denmark
Site 0487, Contact

Region Midt

Local Institution - 0488, Aarhus, Region Midt, 8200, Denmark
Site 0488, Contact

Region Syddanmark

Local Institution - 0486, Odense C, Region Syddanmark, 5000, Denmark
Site 0486, Contact
Local Institution - 0489, Copenhagen, 2100, Denmark
Site 0489, Contact

Laensi-Suomen Laeaeni

Local Institution - 0491, Turku, Laensi-Suomen Laeaeni, 20521, Finland
Site 0491, Contact
Local Institution - 0490, Helsinki, 00290, Finland
Site 0490, Contact

Auvergne-Rhône-Alpes

Local Institution - 0245, Grenoble, Auvergne-Rhône-Alpes, 38043, France
Site 0245, Contact

Maine-et-Loire

Local Institution - 0236, Angers, Maine-et-Loire, 49933, France
Site 0236, Contact

Pays de la Loire Region

Local Institution - 0246, Nantes, Pays de la Loire Region, 44093, France
Site 0246, Contact

Provence-Alpes-Côte d'Azur Region

Local Institution - 0243, Marseille, Provence-Alpes-Côte d'Azur Region, 13015, France
Site 0243, Contact
Local Institution - 0242, Bobigny, 93009, France
Site 0242, Contact
Local Institution - 0238, Brest, 29609, France
Site 0238, Contact
Local Institution - 0244, Dijon, 21000, France
Site 0244, Contact
Local Institution - 0240, Nice, 06000, France
Site 0240, Contact
Local Institution - 0239, Paris, 75018, France
Site 0239, Contact
Local Institution - 0241, Pessac, 33604, France
Site 0241, Contact
Local Institution - 0247, Saint-Genis-Laval, 69563, France
Site 0247, Contact
Local Institution - 0237, Toulouse, 31059, France
Site 0237, Contact

Dublin

Local Institution - 0495, Tallaght, Dublin, 0, Ireland
Site 0495, Contact

Louth

Local Institution - 0493, Drogheda, Louth, A92 VW28, Ireland
Local Institution - 0494, Dublin, 0, Ireland
Site 0494, Contact
Local Institution - 0492, Dublin, D15 X40D, Ireland
Site 0492, Contact

Aguascalientes

Local Institution - 0019, Aguascalientes, Aguascalientes, 20116, Mexico
Site 0019, Contact

Chihuahua

Local Institution - 0037, Chihuahua City, Chihuahua, 31203, Mexico
Site 0037, Contact

DIF

Local Institution - 0036, México, DIF, 14050, Mexico
Site 0036, Contact

Edo de Mexico

Local Institution - 0023, Metepec, Edo de Mexico, 52170, Mexico
Site 0023, Contact

Jalisco

Local Institution - 0022, Guadalajara, Jalisco, 44160, Mexico
Site 0022, Contact
Local Institution - 0021, Guadalajara, Jalisco, 44340, Mexico
Site 0021, Contact

Michoacán

Local Institution - 0024, Morelia, Michoacán, 58260, Mexico
Site 0024, Contact

Nuevo León

Local Institution - 0038, Monterrey, Nuevo León, 64460, Mexico
Site 0038, Contact

Oaxaca

Local Institution - 0017, Oaxaca City, Oaxaca, 68000, Mexico
Site 0017, Contact
Local Institution - 0020, Oaxaca City, Oaxaca, 68020, Mexico
Site 0020, Contact

Yucatán

Local Institution - 0035, Col Garcia Binersa, Yucatán, 97070, Mexico
Site 0035, Contact
Local Institution - 0034, Mérida, Yucatán, 97125, Mexico
Site 0034, Contact
Local Institution - 0018, Guadalajara, 44130, Mexico
Site 0018, Contact

South Holland

Local Institution - 0256, Rotterdam, South Holland, 3061BC, Netherlands
Site 0256, Contact
Local Institution - 0253, Amsterdam, 1081 BT, Netherlands
Site 0253, Contact
Local Institution - 0257, Heerlen, 6419 PC, Netherlands
Site 0257, Contact
Local Institution - 0254, Leiden, 2300 RC, Netherlands
Site 0254, Contact
Local Institution - 0255, Nieuwegein, 3425 CM, Netherlands
Site 0255, Contact

LIM

Local Institution - 0063, Lima, LIM, 15033, Peru
Site 0063, Contact
Local Institution - 0059, San Miguel, LIM, 15088, Peru
Site 0059, Contact
Local Institution - 0058, Lima, 15023, Peru
Site 0058, Contact
Local Institution - 0061, Lima, 15073, Peru
Site 0061, Contact
Local Institution - 0064, Lima, Lima 27, Peru
Site 0064, Contact
Local Institution - 0060, Lima, LIMA 31, Peru
Site 0060, Contact
Local Institution - 0065, Lima, Lima 41, Peru
Site 0065, Contact
Local Institution - 0062, Piura, 20001, Peru
Site 0062, Contact

Porto District

Local Institution - 0081, Vila Nova de Gaia, Porto District, 4434-502, Portugal
Site 0081, Contact
Local Institution - 0077, Lisbon, 1769-001, Portugal
Site 0077, Contact
Local Institution - 0078, Loures, 2674-514, Portugal
Site 0078, Contact
Local Institution - 0079, Porto, 4099-001, Portugal
Site 0079, Contact
Local Institution - 0082, Porto, 4200-319, Portugal
Site 0082, Contact
Local Institution - 0195, Seoul, 140-887, South Korea
Site 0195, Contact

Cantabria

Local Institution - 0083, Santander, Cantabria, 39008, Spain
Site 0083, Contact

C

Local Institution - 0085, Santiago de Compostela, C, 15706, Spain
Site 0085, Contact
Local Institution - 0069, Barcelona, 08036, Spain
Site 0069, Contact
Local Institution - 0074, Barcelona, 08907, Spain
Site 0074, Contact
Local Institution - 0075, Barcelona, 8035, Spain
Site 0075, Contact
Local Institution - 0071, Coslada, 28822, Spain
Site 0071, Contact
Local Institution - 0073, Girona, 17001, Spain
Site 0073, Contact
Local Institution - 0068, Madrid, 28006, Spain
Site 0068, Contact
Local Institution - 0067, Madrid, 28040, Spain
Site 0067, Contact
Local Institution - 0084, Madrid, 28040, Spain
Site 0084, Contact
Local Institution - 0072, Madrid, 28046, Spain
Site 0072, Contact
Local Institution - 0076, Málaga, 29010, Spain
Site 0076, Contact
Local Institution - 0070, Oviedo, 33006, Spain
Site 0070, Contact
Local Institution - 0323, Kaohsiung City, 807, Taiwan
Site 0323, Contact
Local Institution - 0321, Kaohsiung City, 83301, Taiwan
Site 0321, Contact
Local Institution - 0322, Taichung, 404332, Taiwan
Site 0322, Contact
Local Institution - 0325, Taichung, 407, Taiwan
Site 0325, Contact
Local Institution - 0324, Taipei, 100, Taiwan
Site 0324, Contact
Local Institution - 0326, Taipei, 112, Taiwan
Site 0326, Contact