Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis

NCT07441408 | Not Yet Recruiting Phase 3 FDA Drug

• 3 other identifiers: IM027-10162025-522373-10U1111-1322-7787
• Study Type: interventional
• Target: 2,277
• Locations: 24 countries
• Sites: 216

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)).

Conditions

Pulmonary Fibrosis

Keywords

LPA1 receptor antagonist; Idiopathic pulmonary fibrosis; Progressive pulmonary fibrosis; Long-term extension; IPF; PPF; IM027068; IM0271015; Follow up

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

BMS-986278 Arm

EXPERIMENTAL

Drug: BMS-986278

Interventions

BMS-986278 DRUG

Specified dose on specified days

Also known as: Admilparant

BMS-986278 Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (216)

Local Institution - 0013

Florida, Vicente López, Buenos Aires, 1602, Argentina

Location

Local Institution - 0014

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Local Institution - 0007

Quilmes, Buenos Aires, 1878, Argentina

Location

Local Institution - 0009

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

Local Institution - 0003

Mar del Plata, B, 7600, Argentina

Location

Local Institution - 0001

Córdoba, Córdoba Province, X5003DCE, Argentina

Location

Local Institution - 0005

CABA, Distrito Federal, C1425FVH, Argentina

Location

Local Institution - 0002

Godoy Cruz, Mendoza Province, 5501, Argentina

Location

Local Institution - 0011

Mendoza, M, 5500, Argentina

Location

Local Institution - 0015

Rosario, S, 2000, Argentina

Location

Local Institution - 0012

San Miguel de Tucumán, Tucumán Province, T4000JCU, Argentina

Location

Local Institution - 0010

Buenos Aires, C1056ABI, Argentina

Location

Local Institution - 0004

Buenos Aires, C1426ABP, Argentina

Location

Local Institution - 0016

CABA, 4190, Argentina

Location

Local Institution - 0006

Mendoza, 5500, Argentina

Location

Local Institution - 0008

Santa Fe, 3000, Argentina

Location

Local Institution - 0287

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0290

Chermside, Queensland, 4032, Australia

Location

Local Institution - 0291

Greenslopes, Queensland, 4120, Australia

Location

Local Institution - 0293

South Brisbane, Queensland, 4101, Australia

Location

Local Institution - 0289

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0288

Frankston, Victoria, 3199, Australia

Location

Local Institution - 0285

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0292

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0286

Melbourne, 3128, Australia

Location

Local Institution - 0284

Wentworthville, NSW2145, Australia

Location

Local Institution - 0249

Yvoir, Namur, 5530, Belgium

Location

Local Institution - 0252

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Local Institution - 0248

Brussels, 1200, Belgium

Location

Local Institution - 0251

Kortrijk, 8500, Belgium

Location

Local Institution - 0250

Liège, 4000, Belgium

Location

Local Institution - 0166

Sherwood Park, Alberta, T8H 0N2, Canada

Location

Local Institution - 0165

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Local Institution - 0168

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Local Institution - 0167

Burlington, Ontario, L7N 3V2, Canada

Location

Local Institution - 0170

Hamilton, Ontario, L8N 4A6, Canada

Location

Local Institution - 0163

Owen Sound, Ontario, N4K 6M9, Canada

Location

Local Institution - 0169

Toronto, Ontario, M5T 3A9, Canada

Location

Local Institution - 0171

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Local Institution - 0172

Montreal, Quebec, H2X 1R9, Canada

Location

Local Institution - 0164

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Local Institution - 0173

Trois-Rivières, Quebec, G9S4P3, Canada

Location

Local Institution - 0054

Concepción, Biobio, 4030000, Chile

Location

Local Institution - 0052

Curicó, Maule Region, 3340000, Chile

Location

Local Institution - 0051

Talca, Maule Region, 3466706, Chile

Location

Local Institution - 0053

Santiago, Santiago Metropolitan, 7620157, Chile

Location

Local Institution - 0050

Quillota, Valparaiso, 2260000, Chile

Location

Local Institution - 0057

Viña del Mar, Valparaiso, 2531172, Chile

Location

Local Institution - 0538

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 0044

Medellín, ANT, 050021, Colombia

Location

Local Institution - 0047

Medellín, ANT, 050034, Colombia

Location

Local Institution - 0043

Bogotá, DC, 110111, Colombia

Location

Local Institution - 0046

Bogotá, DC, 110131, Colombia

Location

Local Institution - 0041

Floridablanca, Santander Department, 681004, Colombia

Location

Local Institution - 0040

Santiago de Cali, VAC, 760046, Colombia

Location

Local Institution - 0039

Bogotá, 0, Colombia

Location

Local Institution - 0048

Bogotá, Colombia

Location

Local Institution - 0042

Manizales, 0, Colombia

Location

Local Institution - 0045

Zipaquirá, 250252, Colombia

Location

Local Institution - 0487

Hellerup, Capital Region, 2900, Denmark

Location

Local Institution - 0488

Aarhus, Region Midt, 8200, Denmark

Location

Local Institution - 0486

Odense C, Region Syddanmark, 5000, Denmark

Location

Local Institution - 0489

Copenhagen, 2100, Denmark

Location

Local Institution - 0491

Turku, Laensi-Suomen Laeaeni, 20521, Finland

Location

Local Institution - 0490

Helsinki, 00290, Finland

Location

Local Institution - 0245

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Location

Local Institution - 0236

Angers, Maine-et-Loire, 49933, France

Location

Local Institution - 0246

Nantes, Pays de la Loire Region, 44093, France

Location

Local Institution - 0243

Marseille, Provence-Alpes-Côte d'Azur Region, 13015, France

Location

Local Institution - 0242

Bobigny, 93009, France

Location

Local Institution - 0238

Brest, 29609, France

Location

Local Institution - 0244

Dijon, 21000, France

Location

Local Institution - 0240

Nice, 06000, France

Location

Local Institution - 0239

Paris, 75018, France

Location

Local Institution - 0241

Pessac, 33604, France

Location

Local Institution - 0247

Saint-Genis-Laval, 69563, France

Location

Local Institution - 0237

Toulouse, 31059, France

Location

Local Institution - 0234

Heraklion, 711 10, Greece

Location

Local Institution - 0229

Ioannina, Ípeiros, 455 00, Greece

Location

Local Institution - 0269

Belagavi, Karnataka, 590010, India

Location

Local Institution - 0263

Nagpur, Maharashtra, 044009, India

Location

Local Institution - 0261

Pune, Maharashtra, 411001, India

Location

Local Institution - 0266

Pune, Maharashtra, 411001, India

Location

Local Institution - 0265

Pune, Maharashtra, 411004, India

Location

Local Institution - 0268

New Delhi, National Capital Territory of Delhi, 110 030, India

Location

Local Institution - 0260

Dehradun, Uttarakhand, 248001, India

Location

Local Institution - 0258

Kolkata, West Bengal, 700014, India

Location

Local Institution - 0270

Kolkata, West Bengal, 700027, India

Location

Local Institution - 0264

Ahemdabad, 380060, India

Location

Local Institution - 0271

Bangalore, 560034, India

Location

Local Institution - 0272

Delhi, 110029, India

Location

Local Institution - 0274

Jaipur, 302039, India

Location

Local Institution - 0259

Lucknow, 226006, India

Location

Local Institution - 0273

Lucknow, 226021, India

Location

Local Institution - 0275

Nagpur, 440010, India

Location

Local Institution - 0495

Tallaght, Dublin, 0, Ireland

Location

Local Institution - 0493

Drogheda, Louth, A92 VW28, Ireland

Location

Local Institution - 0494

Dublin, 0, Ireland

Location

Local Institution - 0492

Dublin, D15 X40D, Ireland

Location

Local Institution - 0279

Petah Tikva, 4941492, Israel

Location

Local Institution - 0211

Florence, Tuscany, 50134, Italy

Location

Local Institution - 0221

Palermo, 90127, Italy

Location

Local Institution - 0516

Nagoya, Aichi-ken, 466-8560, Japan

Location

Local Institution - 0517

Seto-shi, Aichi-ken, 489-8642, Japan

Location

Local Institution - 0512

Kamogawa-Shi, Chiba, 296-0041, Japan

Location

Local Institution - 0536

Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan

Location

Local Institution - 0530

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Local Institution - 0528

Fukuoka, Fukuoka, 810-8563, Japan

Location

Local Institution - 0531

Iizuka-shi, Fukuoka, 820-8505, Japan

Location

Local Institution - 0532

Kurume-Shi, Fukuoka, 830-0011, Japan

Location

Local Institution - 0537

Kōriyama, Fukushima, 963-0197, Japan

Location

Local Institution - 0526

Hiroshima, Hiroshima, 734-8530, Japan

Location

Local Institution - 0498

Sapporo, Hokai-do, 060-8543, Japan

Location

Local Institution - 0499

Sapporo, Hokkaido, 060-8648, Japan

Location

Local Institution - 0524

Himeji-Shi, Hyōgo, 670-8520, Japan

Location

Local Institution - 0523

Kobe, Hyōgo, 650-0047, Japan

Location

Local Institution - 0513

Naka-gun, Ibaraki, 319-1113, Japan

Location

Local Institution - 0510

Yokohama, Kanagawa, 2360051, Japan

Location

Local Institution - 0518

Matsusaka-shi, Mie-ken, 515-8544, Japan

Location

Local Institution - 0522

Tenri-shi, Nara, 632-8552, Japan

Location

Local Institution - 0535

Ginowan-Shi, Okinawa, 901-2214, Japan

Location

Local Institution - 0520

Sakai, Osaka, 590-0197, Japan

Location

Local Institution - 0521

Sakai, Osaka, 591-8555, Japan

Location

Local Institution - 0519

Takatsuki, Osaka, 569-8686, Japan

Location

Local Institution - 0525

Izumo-shi, Shimane, 693-8501, Japan

Location

Local Institution - 0515

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Local Institution - 0514

Shimotsuke, Tochigi, 329-0498, Japan

Location

Local Institution - 0502

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Local Institution - 0503

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Local Institution - 0504

Bunkyo-Ku, Tokyo, 113-8603, Japan

Location

Local Institution - 0501

Minato-ku, Tokyo, 105-8471, Japan

Location

Local Institution - 0509

Mitaka-shi, Tokyo, 181-8611, Japan

Location

Local Institution - 0505

Ōta-ku, Tokyo, 143-8541, Japan

Location

Local Institution - 0508

Shinjyu-Ku, Tokyo, 162-8655, Japan

Location

Local Institution - 0527

Ube, Yamaguchi, 755-0241, Japan

Location

Local Institution - 0511

Chiba, 260-8677, Japan

Location

Local Institution - 0529

Fukuoka, 812-8582, Japan

Location

Local Institution - 0534

Kumamoto, 861-4193, Japan

Location

Local Institution - 0533

Nagasaki, 852-8501, Japan

Location

Local Institution - 0507

Shinjyuku-ku, 160-0023, Japan

Location

Local Institution - 0500

Tokyo, 105-8470, Japan

Location

Local Institution - 0506

Tokyo, 153-8515, Japan

Location

Local Institution - 0019

Aguascalientes, Aguascalientes, 20116, Mexico

Location

Local Institution - 0037

Chihuahua City, Chihuahua, 31203, Mexico

Location

Local Institution - 0036

México, DIF, 14050, Mexico

Location

Local Institution - 0023

Metepec, Edo de Mexico, 52170, Mexico

Location

Local Institution - 0022

Guadalajara, Jalisco, 44160, Mexico

Location

Local Institution - 0021

Guadalajara, Jalisco, 44340, Mexico

Location

Local Institution - 0024

Morelia, Michoacán, 58260, Mexico

Location

Local Institution - 0038

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution - 0017

Oaxaca City, Oaxaca, 68000, Mexico

Location

Local Institution - 0020

Oaxaca City, Oaxaca, 68020, Mexico

Location

Local Institution - 0035

Col Garcia Binersa, Yucatán, 97070, Mexico

Location

Local Institution - 0034

Mérida, Yucatán, 97125, Mexico

Location

Local Institution - 0018

Guadalajara, 44130, Mexico

Location

Local Institution - 0256

Rotterdam, South Holland, 3061BC, Netherlands

Location

Local Institution - 0253

Amsterdam, 1081 BT, Netherlands

Location

Local Institution - 0257

Heerlen, 6419 PC, Netherlands

Location

Local Institution - 0254

Leiden, 2300 RC, Netherlands

Location

Local Institution - 0255

Nieuwegein, 3425 CM, Netherlands

Location

Local Institution - 0063

Lima, LIM, 15033, Peru

Location

Local Institution - 0059

San Miguel, LIM, 15088, Peru

Location

Local Institution - 0058

Lima, 15023, Peru

Location

Local Institution - 0061

Lima, 15073, Peru

Location

Local Institution - 0064

Lima, Lima 27, Peru

Location

Local Institution - 0060

Lima, LIMA 31, Peru

Location

Local Institution - 0065

Lima, Lima 41, Peru

Location

Local Institution - 0062

Piura, 20001, Peru

Location

Local Institution - 0081

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Local Institution - 0077

Lisbon, 1769-001, Portugal

Location

Local Institution - 0078

Loures, 2674-514, Portugal

Location

Local Institution - 0079

Porto, 4099-001, Portugal

Location

Local Institution - 0082

Porto, 4200-319, Portugal

Location

Local Institution - 0203

Ulsan, Dong-gu, 682-714, South Korea

Location

Local Institution - 0206

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

Local Institution - 0197

Busan, Pusan-Kwangyǒkshi, 0, South Korea

Location

Local Institution - 0199

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Local Institution - 0200

Seoul, Seoul-teukbyeolsi, 05505, South Korea

Location

Local Institution - 0208

Bucheon-si, 14584, South Korea

Location

Local Institution - 0207

Bucheon-si, 420-717, South Korea

Location

Local Institution - 0198

Busan, 612-030, South Korea

Location

Local Institution - 0196

Goyang, 411-706, South Korea

Location

Local Institution - 0204

Iksan, 570-711, South Korea

Location

Local Institution - 0205

Incheon, 405-760, South Korea

Location

Local Institution - 0209

Kyunggi-do, 463-707, South Korea

Location

Local Institution - 0202

Seoul, 120-752, South Korea

Location

Local Institution - 0195

Seoul, 140-887, South Korea

Location

Local Institution - 0201

Suwon, 16499, South Korea

Location

Local Institution - 0083

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0085

Santiago de Compostela, C, 15706, Spain

Location

Local Institution - 0069

Barcelona, 08036, Spain

Location

Local Institution - 0074

Barcelona, 08907, Spain

Location

Local Institution - 0075

Barcelona, 8035, Spain

Location

Local Institution - 0071

Coslada, 28822, Spain

Location

Local Institution - 0073

Girona, 17001, Spain

Location

Local Institution - 0068

Madrid, 28006, Spain

Location

Local Institution - 0067

Madrid, 28040, Spain

Location

Local Institution - 0084

Madrid, 28040, Spain

Location

Local Institution - 0072

Madrid, 28046, Spain

Location

Local Institution - 0076

Málaga, 29010, Spain

Location

Local Institution - 0070

Oviedo, 33006, Spain

Location

Local Institution - 0323

Kaohsiung City, 807, Taiwan

Location

Local Institution - 0321

Kaohsiung City, 83301, Taiwan

Location

Local Institution - 0322

Taichung, 404332, Taiwan

Location

Local Institution - 0325

Taichung, 407, Taiwan

Location

Local Institution - 0324

Taipei, 100, Taiwan

Location

Local Institution - 0326

Taipei, 112, Taiwan

Location

Local Institution - 0316

Birmingham, BIR, B9 5SS, United Kingdom

Location

Local Institution - 0317

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

Local Institution - 0312

Edinburgh, EDH, EH16 4SA, United Kingdom

Location

Local Institution - 0315

London, Greater London, SW3 6NP, United Kingdom

Location

Local Institution - 0314

Peterborough, PTE, PE3 9GZ, United Kingdom

Location

Local Institution - 0497

Cottingham, Yorkshire and the Humber, HU16 5JQ, United Kingdom

Location

Local Institution - 0496

Leeds, Yorkshire, LS9 7TF, United Kingdom

Location

Local Institution - 0319

Birmingham, B15 2WB, United Kingdom

Location

Local Institution - 0318

Oxford, OX3 7LE, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 2, 2026
• Study Start (Estimated): December 16, 2026
• Primary Completion (Estimated): November 22, 2029
• Study Completion (Estimated): March 30, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CO (10); CN (1); GB (9); CA (11); IN (16); FR (12); BE (5); IE (4); IL (1); GR (2); JP (40); IT (2); ME (13); PE (8); KR (15); NL (5); CL (6); FI (2); ES (13); AR (16); PT (5); TW (6); AU (10); DK (4)