Pulmonary FibrosisPhase 3NCT07441408
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
A Phase 3 study testing BMS-986278 in people with Pulmonary Fibrosis, run by Bristol-Myers Squibb at 275 sites in 27 countries.
Trial 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)). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- BMS-986278
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,380 participants
- Where
- 275 sitesin 27 countries
- Study dates
- 16 Dec 2026to 30 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must have participated in either IM027068 or IM0271015 without discontinuing treatment permanently due to withdrawal of informed consent in either IM027068 or IM0271015.
Who cannot join
- Any disease/condition that, in the investigator's judgment, may pose an unacceptable safety risk for study participation.
- Any AE that resulted in permanent discontinuation of IMP in IM027068 or IM0271015.
- Exhibit symptoms of heart failure at rest.
- History of lung reduction surgery or lung transplant.
- 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.
Trial locations and contacts
275 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
275 sites in 27 countries
China40 sites
Local Institution - 0555
Beijing, Beijing Municipality, 100020
Site 0555
Local Institution - 0558
Beijing, Beijing Municipality, 100050
Site 0558
Local Institution - 0538
Beijing, Beijing Municipality, 100730
Site 0538
Local Institution - 0549
Changsha, Hunan, 410011
Site 0549
Local Institution - 0541
Chengdu, SC, 610041
Site 0541
Local Institution - 0550
Chengdu, Sichuan, 610015
Site 0550
Local Institution - 0543
Guangzhou, Guangdong, 510120
Site 0543
Local Institution - 0553
Guangzhou, Guangdong, 510515
Site 0553
Local Institution - 0574
Hangzhou, Zhejiang, 310009
Site 0574
Local Institution - 0576
Hangzhou, Zhejiang, 310016
Site 0576
Local Institution - 0552
Hangzhou, ZJ, 310006
Site 0552
Local Institution - 0563
Hefei, AH, 230022
Site 0563
Local Institution - 0569
Hefei, Anhui, 230031
Site 0569
Local Institution - 0540
Hohhot, 010010
Site 0540
Local Institution - 0559
Lanzhou, 730000
Site 0559
Local Institution - 0542
Nanjing, 210008
Site 0542
Local Institution - 0571
Ningbo, Zhejiang, 315010
Site 0571
Local Institution - 0548
Shandong, Shandong, 250012
Site 0548
Local Institution - 0575
Shanghai, Shanghai Municipality, 200032
Site 0575
Local Institution - 0572
Shanghai, Shanghai Municipality, 200233
Local Institution - 0566
Shanghai, 200040
Site 0566
Local Institution - 0562
Shanghai, 200092
Site 0562
Local Institution - 0565
Shanghai, 200127
Site 0565
Local Institution - 0546
Shanghai Shi, 200030
Site 0546
Local Institution - 0551
Shenyang, Liaoning, 110001
Site 0551
Local Institution - 0554
Shenyang, Liaoning, 110044
Site 0554
Local Institution - 0557
Shenzhen, GD, 518116
Site 0557
Local Institution - 0561
Shenzhen Shi, Guangdong, 518020
Site 0561
Local Institution - 0544
Shijiazhuang, HE, 050051
Site 0544
Local Institution - 0573
Suzhou, Jiangsu, 215008
Site 0573
Local Institution - 0547
Tianjin, Tianjin Municipality, 300052
Site 0547
Local Institution - 0577
Tianjin, TJ, 300222
Site 0577
Local Institution - 0556
Wuhan, Hubei, 430002
Site 0556
Local Institution - 0570
Wuxi, Jiangsu, 214023
Site 0570
Local Institution - 0564
Xi'an, 710100
Site 0564
Local Institution - 0545
Xuzhou, 221002
Site 0545
Local Institution - 0568
Yichang Shi, HE, 443099
Site 0568
Local Institution - 0560
Yinchuan, 750004
Site 0560
Local Institution - 0539
Zhengzhou, Henan, 450000
Site 0539
Local Institution - 0567
Zhengzhou, Henan, 450052
Site 0567
Japan40 sites
Local Institution - 0502
Bunkyo-ku, Tokyo, 113-8431
Site 0502
Local Institution - 0503
Bunkyo-ku, Tokyo, 113-8519
Site 0503
Local Institution - 0504
Bunkyo-Ku, Tokyo, 113-8603
Site 0504
Local Institution - 0511
Chiba, 260-8677
Site 0511
Local Institution - 0530
Chikushino-shi, Fukuoka, 818-8502
Site 0530
Local Institution - 0536
Eiheiji-cho, Yoshida-gun, Fukui, 910-1193
Site 0536
Local Institution - 0528
Fukuoka, Fukuoka, 810-8563
Site 0528
Local Institution - 0529
Fukuoka, 812-8582
Site 0529
Local Institution - 0535
Ginowan-Shi, Okinawa, 901-2214
Site 0535
Local Institution - 0515
Hamamatsu, Shizuoka, 431-3192
Site 0515
Local Institution - 0524
Himeji-Shi, Hyōgo, 670-8520
Site 0524
Local Institution - 0526
Hiroshima, Hiroshima, 734-8530
Site 0526
Local Institution - 0531
Iizuka-shi, Fukuoka, 820-8505
Site 0531
Local Institution - 0525
Izumo-shi, Shimane, 693-8501
Site 0525
Local Institution - 0512
Kamogawa-Shi, Chiba, 296-0041
Site 0512
Local Institution - 0523
Kobe, Hyōgo, 650-0047
Site 0523
Local Institution - 0537
Kōriyama, Fukushima, 963-0197
Site 0537
Local Institution - 0534
Kumamoto, 861-4193
Site 0534
Local Institution - 0532
Kurume-Shi, Fukuoka, 830-0011
Site 0532
Local Institution - 0518
Matsusaka-shi, Mie-ken, 515-8544
Site 0518
Local Institution - 0501
Minato-ku, Tokyo, 105-8471
Site 0501
Local Institution - 0509
Mitaka-shi, Tokyo, 181-8611
Site 0509
Local Institution - 0533
Nagasaki, 852-8501
Site 0533
Local Institution - 0516
Nagoya, Aichi-ken, 466-8560
Site 0516
Local Institution - 0513
Naka-gun, Ibaraki, 3191113
Site 0513
Local Institution - 0505
Ōta-ku, Tokyo, 143-8541
Site 0505
Local Institution - 0520
Sakai, Osaka, 590-0197
Site 0520
Local Institution - 0521
Sakai, Osaka, 591-8555
Site 0521
Local Institution - 0498
Sapporo, Hokai-do, 060-8543
Site 0498
Local Institution - 0499
Sapporo, Hokkaido, 060-8648
Site 0499
Local Institution - 0517
Seto-shi, Aichi-ken, 489-8642
Site 0517
Local Institution - 0514
Shimotsuke, Tochigi, 329-0498
Site 0514
Local Institution - 0508
Shinjyu-Ku, Tokyo, 162-8655
Site 0508
Local Institution - 0507
Shinjyuku-ku, 160-0023
Site 0507
Local Institution - 0519
Takatsuki, Osaka, 569-8686
Site 0519
Local Institution - 0522
Tenri-shi, Nara, 632-8552
Site 0522
Local Institution - 0500
Tokyo, 105-8470
Site 0500
Local Institution - 0506
Tokyo, 153-8515
Site 0506
Local Institution - 0527
Ube, Yamaguchi, 755-0241
Site 0527
Local Institution - 0510
Yokohama, Kanagawa, 2360051
Site 0510
Argentina16 sites
Local Institution - 0010
Buenos Aires, C1056ABI
Site 0010
Local Institution - 0004
Buenos Aires, C1426ABP
Site 0004
Local Institution - 0005
CABA, Distrito Federal, C1425FVH
Site 0005
Local Institution - 0016
CABA, 4190
Site 0016
Local Institution - 0001
Córdoba, Córdoba Province, X5003DCE
Site 0001
Local Institution - 0013
Florida, Vicente López, Buenos Aires, 1602
Site 0013
Local Institution - 0002
Godoy Cruz, Mendoza Province, 5501
Site 0002
Local Institution - 0014
Mar del Plata, Buenos Aires, 7600
Site 0014
Local Institution - 0003
Mar del Plata, B, 7600
Site 0003
Local Institution - 0011
Mendoza, M, 5500
Site 0011
Local Institution - 0006
Mendoza, 5500
Site 0006
Local Institution - 0007
Quilmes, Buenos Aires, 1878
Local Institution - 0015
Rosario, S, 2000
Site 0015
Local Institution - 0009
San Juan Bautista, Buenos Aires, 1888
Site 0009
Local Institution - 0012
San Miguel de Tucumán, Tucumán Province, T4000JCU
Site 0012
Local Institution - 0008
Santa Fe, 3000
Site 0008
India16 sites
Local Institution - 0264
Ahemdabad, 380060
Site 0264
Local Institution - 0271
Bangalore, 560034
Site 0271
Local Institution - 0269
Belagavi, Karnataka, 590010
Site 0269
Local Institution - 0260
Dehradun, Uttarakhand, 248001
Site 0260
Local Institution - 0272
Delhi, 110029
Site 0272
Local Institution - 0274
Jaipur, 302039
Site 0274
Local Institution - 0258
Kolkata, West Bengal, 700014
Site 0258
Local Institution - 0270
Kolkata, West Bengal, 700027
Site 0270
Local Institution - 0259
Lucknow, 226006
Site 0259
Local Institution - 0273
Lucknow, 226021
Site 0273
Local Institution - 0263
Nagpur, Maharashtra, 044009
Site 0263
Local Institution - 0275
Nagpur, 440010
Site 0275
Local Institution - 0268
New Delhi, National Capital Territory of Delhi, 110 030
Site 0268
Local Institution - 0261
Pune, Maharashtra, 411001
Site 0261
Local Institution - 0266
Pune, Maharashtra, 411001
Site 0266
Local Institution - 0265
Pune, Maharashtra, 411004
Site 0265
South Korea15 sites
Local Institution - 0208
Bucheon-si, 14584
Site 0208
Local Institution - 0207
Bucheon-si, 420-717
Site 0207
Local Institution - 0197
Busan, Pusan-Kwangyǒkshi, 0
Site 0197
Local Institution - 0198
Busan, 612-030
Site 0198
Local Institution - 0196
Goyang, 411-706
Local Institution - 0206
Goyang-si, Gyeonggi-do, 10475
Site 0206
Local Institution - 0204
Iksan, 570-711
Site 0204
Local Institution - 0209
Kyunggi-do, 463-707
Site 0209
Local Institution - 0205
Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565
Site 0205
Local Institution - 0200
Seoul, Seoul-teukbyeolsi, 05505
Site 0200
Local Institution - 0199
Seoul, 03080
Site 0199
Local Institution - 0202
Seoul, 120-752
Site 0202
Local Institution - 0195
Seoul, 140-887
Site 0195
Local Institution - 0201
Suwon, 16499
Site 0201
Local Institution - 0203
Ulsan, Dong-gu, 682-714
Site 0203
Brazil13 sites
Local Institution - 0194
Barra Mansa, Rio de Janeiro, 27323-240
Site 0194
Local Institution - 0086
Belo Horizonte, Minas Gerais, 30130-100
Site 0086
Local Institution - 0031
Belo Horizonte, Minas Gerais, 30430-142
Local Institution - 0030
Blumenau, Santa Catarina, 89030-100
Site 0030
Local Institution - 0033
Botucatu, São Paulo, 18618-687
Local Institution - 0027
Porto Alegre, Rio Grande do Sul, 90160-092
Site 0027
Local Institution - 0028
Porto Alegre, Rio Grande do Sul, 9050-170
Site 0028
Local Institution - 0032
Porto Alegre, Rio Grande do Sul, 90610-000
Site 0032
Local Institution - 0193
Rio de Janeiro, 20551-030
Site 0193
Local Institution - 0026
Santo André, São Paulo, 09060-870
Site 0026
Local Institution - 0025
Santo André, 09190-510
Site 0025
Local Institution - 0066
São Paulo, 01323-020
Site 0066
Local Institution - 0192
São Paulo, 04023-062
Site 0192
Mexico13 sites
Local Institution - 0019
Aguascalientes, Aguascalientes, 20116
Local Institution - 0037
Chihuahua City, Chihuahua, 31203
Site 0037
Local Institution - 0035
Col Garcia Binersa, Yucatán, 97070
Site 0035
Local Institution - 0022
Guadalajara, Jalisco, 44160
Site 0022
Local Institution - 0021
Guadalajara, Jalisco, 44340
Site 0021
Local Institution - 0018
Guadalajara, 44130
Site 0018
Local Institution - 0034
Mérida, Yucatán, 97125
Site 0034
Local Institution - 0023
Metepec, Edo de Mexico, 52170
Site 0023
Local Institution - 0036
México, DIF, 14050
Site 0036
Local Institution - 0038
Monterrey, Nuevo León, 64460
Local Institution - 0024
Morelia, Michoacán, 58260
Site 0024
Local Institution - 0017
Oaxaca City, Oaxaca, 68000
Site 0017
Local Institution - 0020
Oaxaca City, Oaxaca, 68020
Spain13 sites
Local Institution - 0069
Barcelona, 08036
Site 0069
Local Institution - 0074
Barcelona, 08907
Local Institution - 0075
Barcelona, 8035
Site 0075
Local Institution - 0071
Coslada, 28822
Site 0071
Local Institution - 0073
Girona, 17001
Site 0073
Local Institution - 0068
Madrid, 28006
Site 0068
Local Institution - 0067
Madrid, 28040
Site 0067
Local Institution - 0084
Madrid, 28040
Site 0084
Local Institution - 0072
Madrid, 28046
Site 0072
Local Institution - 0076
Málaga, 29010
Local Institution - 0070
Oviedo, 33006
Site 0070
Local Institution - 0083
Santander, Cantabria, 39008
Site 0083
Local Institution - 0085
Santiago de Compostela, C, 15706
Site 0085
France12 sites
Local Institution - 0236
Angers, Maine-et-Loire, 49933
Site 0236
Local Institution - 0242
Bobigny, 93009
Site 0242
Local Institution - 0238
Brest, 29609
Site 0238
Local Institution - 0244
Dijon, 21000
Site 0244
Local Institution - 0245
Grenoble, Auvergne-Rhône-Alpes, 38043
Site 0245
Local Institution - 0243
Marseille, Provence-Alpes-Côte d'Azur Region, 13015
Site 0243
Local Institution - 0246
Nantes, Pays de la Loire Region, 44093
Site 0246
Local Institution - 0240
Nice, 06000
Site 0240
Local Institution - 0239
Paris, 75018
Site 0239
Local Institution - 0241
Pessac, 33604
Site 0241
Local Institution - 0247
Saint-Genis-Laval, 69563
Site 0247
Local Institution - 0237
Toulouse, 31059
Canada11 sites
Local Institution - 0167
Burlington, Ontario, L7N 3V2
Site 0167
Local Institution - 0171
Greenfield Park, Quebec, J4V 2H1
Local Institution - 0170
Hamilton, Ontario, L8N 4A6
Site 0170
Local Institution - 0172
Montreal, Quebec, H2X 1R9
Site 0172
Local Institution - 0163
Owen Sound, Ontario, N4K 6M9
Site 0163
Local Institution - 0166
Sherwood Park, Alberta, T8H 0N2
Site 0166
Local Institution - 0169
Toronto, Ontario, M5T 3A9
Site 0169
Local Institution - 0164
Trois-Rivières, Quebec, G8T 7A1
Site 0164
Local Institution - 0173
Trois-Rivières, Quebec, G9S4P3
Local Institution - 0165
Vancouver, British Columbia, V5Z 1M9
Site 0165
Local Institution - 0168
Vancouver, British Columbia, V6Z 1Y6
Site 0168
Australia10 sites
Local Institution - 0289
Adelaide, South Australia, 5000
Site 0289
Local Institution - 0287
Camperdown, New South Wales, 2050
Site 0287
Local Institution - 0290
Chermside, Queensland, 4032
Site 0290
Local Institution - 0288
Frankston, Victoria, 3199
Local Institution - 0291
Greenslopes, Queensland, 4120
Site 0291
Local Institution - 0286
Melbourne, 3128
Site 0286
Local Institution - 0285
Murdoch, Western Australia, 6150
Site 0285
Local Institution - 0292
Nedlands, Western Australia, 6009
Site 0292
Local Institution - 0293
South Brisbane, Queensland, 4101
Site 0293
Local Institution - 0284
Wentworthville, NSW2145
Site 0284
Colombia10 sites
Local Institution - 0043
Bogotá, DC, 110111
Site 0043
Local Institution - 0046
Bogotá, DC, 110131
Site 0046
Local Institution - 0039
Bogotá, 0
Site 0039
Local Institution - 0048
Bogotá
Site 0048
Local Institution - 0041
Floridablanca, Santander Department, 681004
Site 0041
Local Institution - 0042
Manizales, 0
Local Institution - 0044
Medellín, ANT, 050021
Site 0044
Local Institution - 0047
Medellín, ANT, 050034
Local Institution - 0040
Santiago de Cali, VAC, 760046
Site 0040
Local Institution - 0045
Zipaquirá, 250252
Site 0045
United Kingdom9 sites
Local Institution - 0316
Birmingham, BIR, B9 5SS
Site 0316
Local Institution - 0319
Birmingham, B15 2WB
Site 0319
Local Institution - 0317
Cambridge, Cambridgeshire, CB2 0AY
Site 0317
Local Institution - 0497
Cottingham, Yorkshire and the Humber, HU16 5JQ
Site 0497
Local Institution - 0312
Edinburgh, EDH, EH16 4SA
Site 0312
Local Institution - 0496
Leeds, Yorkshire, LS9 7TF
Site 0496
Local Institution - 0315
London, Greater London, SW3 6NP
Site 0315
Local Institution - 0318
Oxford, OX3 7LE
Site 0318
Local Institution - 0314
Peterborough, PTE, PE3 9GZ
Site 0314
Chile8 sites
Local Institution - 0054
Concepción, Biobio, 4030000
Site 0054
Local Institution - 0052
Curicó, Maule Region, 3340000
Site 0052
Local Institution - 0050
Quillota, Valparaiso, 2260000
Site 0050
Local Institution - 0053
Santiago, Santiago Metropolitan, 7620157
Site 0053
Local Institution - 0055
Santiago, Santiago Metropolitan, 7750495
Site 0055
Local Institution - 0051
Talca, Maule Region, 3466706
Site 0051
Local Institution - 0029
Talcahuano, BI, 4260000
Site 0029
Local Institution - 0057
Viña del Mar, Valparaiso, 2531172
Site 0057
Peru8 sites
Local Institution - 0063
Lima, LIM, 15033
Site 0063
Local Institution - 0058
Lima, 15023
Site 0058
Local Institution - 0061
Lima, 15073
Site 0061
Local Institution - 0064
Lima, Lima 27
Site 0064
Local Institution - 0060
Lima, LIMA 31
Site 0060
Local Institution - 0065
Lima, Lima 41
Site 0065
Local Institution - 0062
Piura, 20001
Site 0062
Local Institution - 0059
San Miguel, LIM, 15088
Site 0059
Taiwan6 sites
Local Institution - 0323
Kaohsiung City, 807
Site 0323
Local Institution - 0321
Kaohsiung City, 83301
Site 0321
Local Institution - 0322
Taichung, 404332
Site 0322
Local Institution - 0325
Taichung, 407
Site 0325
Local Institution - 0324
Taipei, 100
Site 0324
Local Institution - 0326
Taipei, 112
Site 0326
Belgium5 sites
Local Institution - 0248
Brussels, 1200
Site 0248
Local Institution - 0251
Kortrijk, 8500
Site 0251
Local Institution - 0252
Leuven, Vlaams-Brabant, 3000
Site 0252
Local Institution - 0250
Liège, 4000
Site 0250
Local Institution - 0249
Yvoir, Namur, 5530
Site 0249
Netherlands5 sites
Local Institution - 0253
Amsterdam, 1081 BT
Site 0253
Local Institution - 0257
Heerlen, 6419 PC
Site 0257
Local Institution - 0254
Leiden, 2300 RC
Site 0254
Local Institution - 0255
Nieuwegein, 3425 CM
Site 0255
Local Institution - 0256
Rotterdam, South Holland, 3061BC
Site 0256
Portugal5 sites
Local Institution - 0077
Lisbon, 1769-001
Site 0077
Local Institution - 0078
Loures, 2674-514
Site 0078
Local Institution - 0079
Porto, 4099-001
Site 0079
Local Institution - 0082
Porto, 4200-319
Site 0082
Local Institution - 0081
Vila Nova de Gaia, Porto District, 4434-502
Site 0081
Denmark4 sites
Local Institution - 0488
Aarhus, Region Midt, 8200
Local Institution - 0489
Copenhagen, 2100
Site 0489
Local Institution - 0487
Hellerup, Capital Region, 2900
Site 0487
Local Institution - 0486
Odense C, Region Syddanmark, 5000
Site 0486
Ireland4 sites
Local Institution - 0493
Drogheda, Louth, A92 VW28
Local Institution - 0494
Dublin, 0
Site 0494
Local Institution - 0492
Dublin, D15 X40D
Local Institution - 0495
Tallaght, Dublin, 0
Site 0495
United States3 sites
Local Institution - 0113
Birmingham, Alabama, 35294
Site 0113
Local Institution - 0111
Ocala, Florida, 34471
Site 0111
Local Institution - 0119
Philadelphia, Pennsylvania, 19140-5103
Site 0119
Finland2 sites
Local Institution - 0490
Helsinki, 00290
Site 0490
Local Institution - 0491
Turku, Laensi-Suomen Laeaeni, 20521
Site 0491
Germany2 sites
Local Institution - 0179
Coswig, Saxony, 01640
Site 0179
Local Institution - 0186
Stralsund, Mecklenburg-Vorpommern, 18435
Site 0186
Greece2 sites
Local Institution - 0234
Heraklion, 711 10
Site 0234
Local Institution - 0229
Ioannina, Ípeiros, 455 00
Site 0229
Italy2 sites
Local Institution - 0211
Florence, Tuscany, 50134
Site 0211
Local Institution - 0221
Palermo, 90127
Site 0221
About this study
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
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
- Being tested
- BMS-986278
- Keywords
- LPA1 receptor antagonist, Idiopathic pulmonary fibrosis, Progressive pulmonary fibrosis, Long-term extension, IPF, PPF, IM027068, IM0271015, Follow up
- Medical subject headings
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986278Drug
Also called Admilparant
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986278 Arm | Experimental | Not described Receives: Drug: BMS-986278 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Week 100
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to Week 100
Number of Participants With AEs leading to Discontinuation
Measured: Up to Week 100
Number of Participants With AEs leading to Deaths
Measured: Up to Week 100
Number of Participants With Clinically Significant Laboraty Abnormalities
Measured: Up to Week 100
Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities
Measured: Up to Week 100
Number of Participants With Clinically Significant Vital Sign Abnormalities
Measured: Up to Week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start16 Dec 2026 (estimated)
- Primary completion22 Nov 2029 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441408
- Sponsor's protocol ID
- IM027-1016
- Other IDs
- 2025-522373-10, U1111-1322-7787, 2025
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07441408
- Acronym / sponsor ID
- IM027-1016
- Conditions
- Pulmonary Fibrosis
- Keywords
- LPA1 receptor antagonist, Idiopathic pulmonary fibrosis, Progressive pulmonary fibrosis, Long-term extension, IPF, PPF, IM027068, IM0271015
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,380 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2026 (estimated)
- Primary completion
- 22 Nov 2029 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986278 Arm | Experimental | Drug: BMS-986278 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must have participated in either IM027068 or IM0271015 without discontinuing treatment permanently due to withdrawal of informed consent in either IM027068 or IM0271015.
Key exclusion criteria (6 listed)
- Any disease/condition that, in the investigator's judgment, may pose an unacceptable safety risk for study participation.
- Any AE that resulted in permanent discontinuation of IMP in IM027068 or IM0271015.
- Exhibit symptoms of heart failure at rest.
- History of lung reduction surgery or lung transplant.
- Participants with known PAH (Pulmonary Arterial Hypertension) who has been on single-drug therapy that now requires multi-drug therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986278Also: AdmilparantSpecified dose on specified days | Drug | BMS-986278 Arm |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 100
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 100
Number of Participants With AEs leading to Discontinuation
Time frame: Up to Week 100
Number of Participants With AEs leading to Deaths
Time frame: Up to Week 100
Number of Participants With Clinically Significant Laboraty Abnormalities
Time frame: Up to Week 100
Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities
Time frame: Up to Week 100
Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Up to Week 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
275 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BMS-986278 in people with Pulmonary Fibrosis, run by Bristol-Myers Squibb at 275 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 275 sites in China, Japan, Argentina, India, South Korea and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Week 100). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.