A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003426
• Other study ID #: IM027-068
• Status: Recruiting
• Phase: Phase 3
• Start date: September 14, 2023
• Est. completion date: October 26, 2026

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1185
• Est. completion date: October 26, 2026
• Est. primary completion date: October 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria

• Subjects with IPF aged = 40 years at the time of signing the informed consent.

• Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.

• If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.

• If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.

• Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.

• Men who are sexually active with women of childbearing potential agree to use male barrier contraception.

Exclusion Criteria

• History of stroke or transient ischemic attack within 3 months prior to screening.

• Participants who exhibit symptoms of heart failure at rest.

• Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.

• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• BMS-986278
Specified dose on specified days
• BMS-986278 Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0019	Buenos Aires	B
Argentina	Local Institution - 0283	Buenos Aires
Argentina	Local Institution - 0446	Buenos Aires
Argentina	Local Institution - 0172	Caba	Distrito Federal
Argentina	Local Institution - 0288	Ciudad Autónoma Buenos Aires	C
Argentina	Local Institution - 0218	Cordoba	X
Argentina	Local Institution - 0290	Florencio Varela	B
Argentina	Local Institution - 0170	Florida	B
Argentina	Local Institution - 0287	Godoy Cruz	M
Argentina	Local Institution - 0131	Mar Del Plata	Buenos Aires
Argentina	Local Institution - 0286	Mar del Plata	B
Argentina	Local Institution - 0013	Mendoza	M
Argentina	Local Institution - 0356	Mendoza	M
Argentina	Local Institution - 0485	Quilmes, Provincia De Buenos Aires	B
Argentina	Local Institution - 0330	Rosario	S
Argentina	Local Institution - 0449	San Fernando	Buenos Aires
Argentina	Local Institution - 0169	San Miguel De Tucumán	T
Argentina	Local Institution - 0173	Santa Fe
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Eastern Health	Box Hill	Victoria
Australia	Local Institution - 0210	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Local Institution - 0474	Chermside	Queensland
Australia	Local Institution - 0293	Darlinghurst	New South Wales
Australia	Peninsula Health - Frankston Hospital	Frankston	Victoria
Australia	Gallipoli Medical Research Centre - Clinical Trials Unit (CTU)	Greenslopes	Queensland
Australia	Local Institution - 0357	Heidelberg	Victoria
Australia	Local Institution - 0253	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Institute for Respiratory Health	Nedlands	Western Australia
Australia	Local Institution - 0421	South Brisbane	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Local Institution - 0460	Graz	Styria
Austria	Local Institution - 0409	Linz	Oberoesterreich
Austria	Local Institution - 0458	Salzburg	Salzburger Land
Austria	Local Institution - 0082	Vienna
Austria	Local Institution - 0025	Wien
Austria	Local Institution - 0459	Wien
Belgium	Local Institution - 0014	Antwerpen	VAN
Belgium	Local Institution - 0075	Brussels
Belgium	Local Institution - 0345	Kortrijk
Belgium	Local Institution - 0038	Leuven
Belgium	Local Institution - 0046	Liège
Belgium	Local Institution - 0332	Yvoir	Namur
Brazil	Local Institution - 0084	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0098	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0089	Blumenau	SC
Brazil	Local Institution - 0049	Porto Alegre	RS
Brazil	Local Institution - 0304	Porto Alegre	RS
Brazil	Local Institution - 0307	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0359	Rio De Janeiro	RJ
Brazil	Local Institution - 0054	Santo André	SP
Brazil	Local Institution - 0305	São Bernardo Do Campo	SP
Brazil	Local Institution - 0486	Sao Paulo
Brazil	Local Institution - 0024	São Paulo	SP
Canada	Burlington Lung Clinic	Burlington	Ontario
Canada	Local Institution - 0208	Edmonton	Alberta
Canada	Local Institution - 0426	Greenfield Park	Quebec
Canada	Local Institution - 0216	Hamilton	Ontario
Canada	Local Institution - 0100	Kelowna	British Columbia
Canada	Local Institution - 0434	Montreal	Quebec
Canada	Local Institution - 0044	Owen Sound	Ontario
Canada	Local Institution - 0215	Quebec
Canada	Local Institution - 0217	Sherbrooke	Quebec
Canada	Synergy Respiratory & Cardiac Care	Sherwood Park	Alberta
Canada	Inspiration Research	Toronto	Ontario
Canada	C.I.C. Mauricie Inc.	Trois-Rivieres	Quebec
Canada	Local Institution - 0478	Trois-Rivieres	Quebec
Canada	Local Institution - 0171	Vancouver	British Columbia
Canada	The Lung Centre	Vancouver	British Columbia
Chile	Local Institution - 0212	Concepción	BI
Chile	Local Institution - 0437	Curicó	Maule
Chile	Local Institution - 0080	Providencia	RM
Chile	Local Institution - 0051	Quillota	VS
Chile	Local Institution - 0068	Santiago	RM
Chile	Local Institution - 0214	Santiago	RM
Chile	Local Institution - 0211	Talca	Maule
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Local Institution - 0470	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changchun	Jilin
China	Local Institution - 0448	Changsha
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital	Chengdu Shi
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Local Institution - 0480	Guangzhou Shi	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou Shi	Guangdong
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Local Institution - 0223	Hangzhou	Zhejiang
China	Local Institution - 0488	Hangzhou Shi	Zhejiang
China	Anhui Medical University - Anhui Chest Hospital	Hefei	AH
China	Anhui Medical University - The Second Hospital - Hematological Research Center	Hefei	Anhui
China	Local Institution - 0263	Hefei	AH
China	Local Institution - 0237	Hohhot
China	Qilu Hospital of Shandong University	Jinan Shi
China	The First Affiliated Hospital of Nanchang University - Xianghu District	Nanchang	Jiangxi
China	Local Institution - 0358	Nanjing
China	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	Local Institution - 0255	Shanghai	Shanghai
China	Local Institution - 0266	Shanghai
China	Local Institution - 0408	Shanghai
China	Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - South Branch	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai
China	Local Institution - 0241	Shenyang	Liaoning
China	Local Institution - 0479	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third Hospital of Hebei Medical University	Shijiazhuang
China	The First Affiliated Hospital of Soochow University	Suzhou Shi	Jiangsu
China	Local Institution - 0365	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Local Institution - 0252	Wuhan	HUB
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Xi'an International Medical Center Hospital	Xi'an
China	Local Institution - 0483	Xuzhou	Jiangsu
China	Local Institution - 0482	Yichang Shi	Hebei
China	Local Institution - 0376	Yinchuan
China	Local Institution - 0294	Zhengzhou	Hainan
China	Local Institution - 0360	Zhengzhou	Hainan
China	Local Institution - 0296	Zhengzhou Shi	Henan
Colombia	Local Institution - 0291	Bogota	DC
Colombia	Local Institution - 0138	Bogotá
Colombia	Local Institution - 0278	Floridablanca	Santander
Colombia	Local Institution - 0279	Manizales
Colombia	Local Institution - 0297	Medellin	ANT
Colombia	Local Institution - 0268	Santiago De Cali	VAC
Czechia	Local Institution - 0063	Brno	JM
Czechia	Local Institution - 0340	Olomouc
Czechia	Local Institution - 0087	Prague
Denmark	Local Institution - 0064	Aarhus	Region Midtjylland
Denmark	Local Institution - 0036	Hellerup
Denmark	Local Institution - 0010	Odense C	Region Syddanmark
Finland	Local Institution - 0328	Helsinki
Finland	Local Institution - 0350	Turku	Laensi-Suomen Laeaeni
France	Local Institution - 0012	Angers
France	Local Institution - 0066	Bobigny
France	Local Institution - 0321	Brest
France	Local Institution - 0047	Bron	Auvergne-Rhône-Alpes
France	Local Institution - 0052	Dijon
France	Local Institution - 0322	Grenoble	Auvergne-Rhône-Alpes
France	Local Institution - 0311	Lille CEDEX
France	Local Institution - 0334	Marseille	Provence-Alpes-Côte d'Azur
France	Local Institution - 0083	Nantes Cedex 01	Pays De La Loire
France	Local Institution - 0091	Nice
France	Local Institution - 0022	Paris
France	Local Institution - 0308	Paris
France	Local Institution - 0342	Pessac
France	Local Institution - 0081	Rennes
France	Local Institution - 0023	Toulouse
France	Local Institution - 0339	Tours
Germany	Local Institution - 0003	Berlin	BE
Germany	Local Institution - 0349	Berlin	BE
Germany	Local Institution - 0320	Cologne	Northwest
Germany	Local Institution - 0004	Coswig
Germany	Local Institution - 0092	Essen	Nordrhein Westfalen
Germany	Local Institution - 0050	Freiburg I. Breisgau	BW
Germany	Local Institution - 0037	Grosshansdorf	SH
Germany	Local Institution - 0313	Hamburg	HH
Germany	Local Institution - 0383	Heidelberg
Germany	Local Institution - 0041	Immenhausen	HE
Germany	Local Institution - 0017	Leipzig
Germany	Local Institution - 0347	Mainz
Germany	Local Institution - 0026	Marburg	HE
Germany	Local Institution - 0272	Munich	Bavaria
Germany	Local Institution - 0042	Munnerstadt	BY
Germany	Local Institution - 0008	Munster	Northwest
Germany	Local Institution - 0315	Stuttgart	BW
Germany	Local Institution - 0006	Wangen I. Allgaeu	BW
Greece	Local Institution - 0110	Athens
Greece	Local Institution - 0108	Corfu
Greece	Local Institution - 0450	Heraklion	Iraklio Kritis
Greece	Local Institution - 0104	Ioannina	Epirus
Greece	Local Institution - 0102	Larisa
Greece	Local Institution - 0314	Maroussi	Attica
Greece	Local Institution - 0454	Pilea Chortiatis	Thessaloniki
Greece	Local Institution - 0318	Pylaia-Chortiatis	B
Greece	Local Institution - 0109	Rio
Hungary	Local Institution - 0018	Budapest
Hungary	Local Institution - 0343	Györ
India	Local Institution - 0427	Ahmedabad	Gujarat
India	Local Institution - 0430	Ahmedabad
India	Local Institution - 0256	Bangalore	Karnataka
India	Local Institution - 0264	Belagavi	KA
India	Local Institution - 0386	Bhopal	MP
India	Local Institution - 0247	Dehradun	UT
India	Local Institution - 0285	Faridabad	HR
India	Local Institution - 0281	Jaipur	RJ
India	Local Institution - 0289	Jaipur	RJ
India	Local Institution - 0225	Kolkata	WB
India	Local Institution - 0228	Lucknow
India	Local Institution - 0477	Lucknow	Uttar Pradesh
India	Local Institution - 0245	Nagpur	MH
India	Local Institution - 0395	Nagpur	MH
India	Local Institution - 0414	Nagpur	MH
India	Local Institution - 0428	New Delhi	Delhi
India	Local Institution - 0429	New Delhi	DL
India	Local Institution - 0381	Noida	UP
India	Local Institution - 0275	Pune	MH
India	Local Institution - 0280	Pune	MH
India	Local Institution - 0457	Pune	Maharashtra
India	Local Institution - 0282	Surat	GJ
India	Local Institution - 0475	Vadodara	Gujarat
Ireland	Local Institution - 0168	Drogheda	LH
Ireland	Local Institution - 0117	Dublin
Israel	Local Institution - 0445	Be'er Sheva
Israel	Carmel Medical Center	Haifa	HA
Israel	Rambam Health Care Campus - Pulmonology	Haifa
Israel	Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem	Jerusalem
Israel	Rabin Medical Center - Hasharon Hospital	Petah-Tikva
Israel	Local Institution - 0035	Rehovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv-Yafo
Italy	Local Institution - 0095	Ancona
Italy	Local Institution - 0118	Bergamo
Italy	Local Institution - 0329	Bologna	BO
Italy	Local Institution - 0034	Firenze	FI
Italy	Local Institution - 0057	Foggia
Italy	Local Institution - 0126	Forli
Italy	Local Institution - 0069	Milan
Italy	Local Institution - 0119	Milano	MI
Italy	Local Institution - 0133	Milano	MI
Italy	Local Institution - 0310	Milano
Italy	Local Institution - 0326	Modena	Emilia-Romagna
Italy	Local Institution - 0121	Monza	Modena
Italy	Local Institution - 0116	Naples
Italy	Local Institution - 0323	Napoli
Italy	Local Institution - 0125	Palermo
Italy	Local Institution - 0122	Pavia
Italy	Local Institution - 0127	Pisa	PI
Italy	Local Institution - 0005	Roma	RM
Italy	Local Institution - 0120	Sassari
Italy	Local Institution - 0114	Siena
Italy	Local Institution - 0115	Trieste	TS
Japan	Juntendo University Hospital	Bunkyo-Ku	TKY
Japan	Nippon Medical School Hospital	Bunkyo-Ku
Japan	Tokyo Medical and Dental University Hospital Institutional Review Board	Bunkyo-Ku	Tokyo
Japan	Local Institution - 0107	Chiba-Shi
Japan	Kurume University Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka-Shi	Fukuoka
Japan	National Hospital Organization - Okinawa National Hospital	Ginowan-Shi
Japan	Hamamatsu University Hospital	Hamamatsu-shi
Japan	National Hospital Organization Himeji Medical Center	Himeji-Shi
Japan	Hiroshima Prefectural Hospital	Hiroshima-shi	Hirohima-ken
Japan	Aso Iizuka Hospital	Iizuka-shi
Japan	Local Institution - 0130	Izumo-Shi
Japan	Kameda Medical Center - Kameda Clinic	Kamogawa-Shi
Japan	Local Institution - 0317	Kitakyushu-shi	Fukuoka-Ken
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Jizankai Medical Foundation Tsuboi Cancer Center Hospital	Koriyama-shi	Fukushima
Japan	Saiseikai Kumamoto Hospital	Kumamoto-Shi
Japan	Matsusaka Municipal Hospital	Matsusaka-shi	Mie
Japan	The Jikei University Hospital	Minato-ku
Japan	Toranomon Hospital	Minato-Ku
Japan	Kyorin University Hospital	Mitaka-shi	Tokyo-to
Japan	Nagasaki University Hospital	Nagasaki-Shi
Japan	Local Institution - 0045	Nagoya
Japan	Local Institution - 0059	Naka-gun	Gunma
Japan	Kindai University Hospital	Osaka-Sayama City
Japan	National Hospital Organization Kinki-chuo Chest Medical Center	Sakai City	OSK
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Tosei General Hospital	Seto
Japan	Local Institution - 0009	Shimotsuge-shi	Tochigi
Japan	Tokyo Medical University Hospital	Shinjuku-Ku
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjyu-Ku
Japan	Tenri Hospital	Tenri-Shi
Japan	Local Institution - 0070	Tokushima-Shi	Tokushima
Japan	Toho University - Omori Medical Center	Tokyo
Japan	Local Institution - 0303	Uruma-shi
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama-Shi
Japan	Local Institution - 0260	Yoshida-Gun
Korea, Republic of	SoonChunHyang University Bucheon Hospital	Bucheon-Si
Korea, Republic of	The Catholic University of Korea, Bucheon St. Mary's Hospital	Bucheonsi Weonmigu
Korea, Republic of	Local Institution - 0316	Deogyang-Gu, Goyang-Si
Korea, Republic of	Myongji Hospital	Deogyang-Gu, Goyang-Si
Korea, Republic of	Ulsan University Hospital (UUH)	Dong-gu	Ulsan
Korea, Republic of	University of Ulsan College of Medicine - Ulsan University Hospital (UUH)	Dong-Gu
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggi-Do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Inje University Haeundae Paik Hospital	Haeundae-Gu
Korea, Republic of	Wonkwang University Hospital	Iksansi
Korea, Republic of	Gachon University - Gil Medical Center	Incheon
Korea, Republic of	Local Institution - 0312	Incheon
Korea, Republic of	Seoul National University Hospital	Jongno-gu	Seoul
Korea, Republic of	Inje University Busan Paik Hospital	Namgu	Busan
Korea, Republic of	Asan Medical Center (AMC)	Seoul
Korea, Republic of	Local Institution - 0397	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon, Gyeonggi-do
Korea, Republic of	SoonChunHyang University Seoul Hospital	Yongsan-gu	Seoul
Malaysia	Local Institution - 0465	Kajang	Selangor Darul Ehsan
Malaysia	Local Institution - 0467	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Local Institution - 0466	Kuching
Mexico	Local Institution - 0141	Aguascalientes	AGU
Mexico	Local Institution - 0277	Chihuahua
Mexico	Local Institution - 0476	Chihuahua	CHH
Mexico	Local Institution - 0163	Córdoba	VER
Mexico	Local Institution - 0136	Guadalajara	JAL
Mexico	Local Institution - 0248	Guadalajara	JAL
Mexico	Local Institution - 0413	Guadalajara
Mexico	Local Institution - 0234	Mérida	YUC
Mexico	Local Institution - 0324	Metepec
Mexico	Local Institution - 0219	Mexico	DIF
Mexico	Local Institution - 0001	Mexico City
Mexico	Local Institution - 0162	Monterrey	Nuevo Leon
Mexico	Local Institution - 0382	Morelia	MIC
Mexico	Local Institution - 0167	Oaxaca	OAX
Mexico	Local Institution - 0422	Oaxaca	OAX
Netherlands	Local Institution - 0032	's-Gravenhage	ZH
Netherlands	Local Institution - 0379	Amsterdam
Netherlands	Local Institution - 0423	Amsterdam
Netherlands	Local Institution - 0152	Heerlen	Limburg
Netherlands	Local Institution - 0456	Nieuwegein
Netherlands	Local Institution - 0394	Rotterdam	South Holland
Peru	Local Institution - 0007	Lima
Peru	Local Institution - 0016	Lima	LIM
Peru	Local Institution - 0055	Lima
Peru	Local Institution - 0220	Lima	LIM
Peru	Local Institution - 0399	Lima	LIM
Peru	Local Institution - 0156	Piura	PIU
Peru	Local Institution - 0144	San Miguel	LIM
Poland	Local Institution - 0076	Bedzin
Poland	Local Institution - 0147	Bialystok	PD
Poland	Local Institution - 0143	Bydgoszcz	KP
Poland	Local Institution - 0145	Bydgoszcz	KP
Poland	Local Institution - 0333	Gdansk	Pomorskie
Poland	Local Institution - 0148	Katowice
Poland	Local Institution - 0327	Kraków	MA
Poland	Local Institution - 0159	Lodz
Poland	Local Institution - 0306	Olsztyn	WN
Portugal	Local Institution - 0453	Braga
Portugal	Local Institution - 0002	Faro
Portugal	Local Institution - 0028	Lisboa
Portugal	Local Institution - 0139	Lisboa
Portugal	Local Institution - 0142	Lisboa
Portugal	Local Institution - 0134	Loures
Portugal	Local Institution - 0137	Porto
Portugal	Local Institution - 0165	Porto
Portugal	Local Institution - 0158	Vila Nova de Gaia
Puerto Rico	Alliance Pulmonary Group	Guaynabo
Puerto Rico	Local Institution - 0444	Guaynabo
Spain	Local Institution - 0020	Badalona
Spain	Local Institution - 0135	Barcelona
Spain	Local Institution - 0341	Barcelona
Spain	Local Institution - 0166	Girona
Spain	Local Institution - 0065	Madrid	M
Spain	Local Institution - 0099	Madrid	M
Spain	Local Institution - 0155	Madrid
Spain	Local Institution - 0161	Madrid
Spain	Local Institution - 0338	Madrid
Spain	Local Institution - 0149	Majadahonda	M
Spain	Local Institution - 0146	Oviedo
Spain	Local Institution - 0335	Pamplona
Spain	Local Institution - 0093	Santander	CB
Spain	Local Institution - 0140	Santiago de Compostela	C
Spain	Local Institution - 0157	Valencia	Comunidad Valencia
Switzerland	Universitätsspital Basel	Basel	BS
Switzerland	Local Institution - 0461	Bern	BE
Switzerland	Local Institution - 0473	Genève	Geneve
Switzerland	Local Institution - 0462	St Gallen
Taiwan	National Taiwan University Hospital Yun-Lin Branch	Douliu Shi	YUN
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Local Institution - 0481	Kaohsiung	Kao-Hsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Local Institution - 0484	Taichung	TXG
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital - The National Center of Excellence for Clinical Trial	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Thailand	Local Institution - 0464	Bangkok
Thailand	Local Institution - 0463	Bangkok-Noi	Bangkok
Thailand	Local Institution - 0469	Hatyai	Songkla
Thailand	Local Institution - 0471	Muang Khon Kaen	Khon Kaen
Thailand	Local Institution - 0468	Mueang Chiang Mai	Chiang Mai
Turkey	Local Institution - 0071	Adana
Turkey	Local Institution - 0177	Ankara
Turkey	Local Institution - 0150	Bursa
Turkey	Local Institution - 0176	Guemueshane
Turkey	Local Institution - 0205	Izmir
Turkey	Local Institution - 0207	Izmir
Turkey	Local Institution - 0451	Keçiören/Ankara
Turkey	Local Institution - 0196	Maltepe
Turkey	Local Institution - 0200	Pasaport
Turkey	Local Institution - 0344	Topkapi
United Kingdom	Local Institution - 0378	Birmingham	BIR
United Kingdom	Local Institution - 0411	Birmingham
United Kingdom	Local Institution - 0415	Bristol	BST
United Kingdom	Local Institution - 0402	Cambridge	Cambridgeshire
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital	Cottingham	Yorkshire And The Humber
United Kingdom	NHS Tayside	Dundee	DND
United Kingdom	NHS Lothian - Royal Infirmary of Edinburgh	Edinburgh	EDH
United Kingdom	Local Institution - 0203	Exeter	South West
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Guy's and St Thomas' NHS Foundation Trust - Royal Brompton Hospital	London	Greater London
United Kingdom	Local Institution - 0432	Nottingham	Nottinghamshire
United Kingdom	Oxford University Hospitals NHS Trust - Churchill Hospital	Oxford	Oxfordshire
United Kingdom	Peterborough City Hospital	Peterborough	PTE
United Kingdom	Local Institution - 0447	South Shields	STY
United Kingdom	Local Institution - 0392	Southampton	Hampshire
United States	AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine	Anderson	South Carolina
United States	Local Institution - 0472	Ann Arbor	Michigan
United States	Local Institution - 0452	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Campus - Department of Family Medicine	Aurora	Colorado
United States	University of Maryland - Marlene and Stewart Greenebaum Cancer Center	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Local Institution - 0439	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Steward St. Elizabeth Medical Center	Boston	Massachusetts
United States	Meris Clinical Research	Brandon	Florida
United States	Medical University of South Carolina- College of Medicine	Charleston	South Carolina
United States	The Lung Research Center	Chesterfield	Missouri
United States	Local Institution - 0058	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building	Chicago	Illinois
United States	Local Institution - 0201	Cincinnati	Ohio
United States	Local Institution - 0436	Clearwater	Florida
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Local Institution - 0073	Dallas	Texas
United States	Local Institution - 0377	Dallas	Texas
United States	Omega Research Consultants LLC	DeBary	Florida
United States	National Jewish Health	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Pulmonology, Sleep, Asthma & Allergy Center of Dublin	Dublin	Georgia
United States	Duke University Medical Center	Durham	North Carolina
United States	Local Institution - 0094	Evanston	Illinois
United States	Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location	Everett	Washington
United States	Local Institution - 0489	Falls Church	Virginia
United States	Local Institution - 0060	Gainesville	Florida
United States	University of Florida (UF) Health Shands Hospital	Gainesville	Florida
United States	Local Institution - 0078	Grand Rapids	Michigan
United States	Local Institution - 0067	Hershey	Pennsylvania
United States	Harmony Medical Research Institute, Inc	Hialeah	Florida
United States	Local Institution - 0039	Houston	Texas
United States	McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location	Houston	Texas
United States	Local Institution - 0190	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Local Institution - 0179	Jasper	Alabama
United States	University of Kansas Medical Center (KUMC)	Kansas City	Kansas
United States	Clinical Research Specialists, LLC - Kissimmee	Kissimmee	Florida
United States	Local Institution - 0112	La Jolla	California
United States	Local Institution - 0396	La Jolla	California
United States	Local Institution - 0193	Los Angeles	California
United States	Local Institution - 0398	Los Angeles	California
United States	Local Institution - 0435	Louisville	Kentucky
United States	Norton Pulmonary Specialists	Louisville	Kentucky
United States	Pulmonary Specialists of the Palm Beaches	Loxahatchee Groves	Florida
United States	Local Institution - 0085	Maywood	Illinois
United States	Metroplex Pulmonary and Sleep Center	McKinney	Texas
United States	Local Institution - 0401	Miami	Florida
United States	Local Institution - 0192	Milwaukee	Wisconsin
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Local Institution - 0390	Nashville	Tennessee
United States	Vanderbilt Lung Institute - One Hundred Oaks	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Local Institution - 0387	New York	New York
United States	Local Institution - 0487	New York	New York
United States	Local Institution - 0151	Newark	Delaware
United States	Local Institution - 0384	Newark	New Jersey
United States	Renstar Medical Research	Ocala	Florida
United States	Local Institution - 0181	Oklahoma City	Oklahoma
United States	UC Irvine Medical Center	Orange	California
United States	Avanza Medical Research Center	Pensacola	Florida
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Local Institution - 0406	Philadelphia	Pennsylvania
United States	Temple University Hospital (TUH) - Temple Lung Center (TLC)	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	(UPMC) - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD)	Pittsburgh	Pennsylvania
United States	Local Institution - 0021	Portland	Oregon
United States	VCU Medical Center	Richmond	Virginia
United States	Local Institution - 0182	Rock Hill	South Carolina
United States	Local Institution - 0405	Sacramento	California
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Coastal Pulmonary & Critical Care, P.L.C.	Saint Petersburg	Florida
United States	University of Utah, University Hospital	Salt Lake City	Utah
United States	Local Institution - 0048	San Antonio	Texas
United States	Local Institution - 0185	San Francisco	California
United States	Local Institution - 0362	Seattle	Washington
United States	Local Institution - 0195	Springfield	Massachusetts
United States	Stanford Hospital and Clinics	Stanford	California
United States	Local Institution - 0364	Tampa	Florida
United States	Infectious Disease Associates Of NW Ohio Inc - Toledo	Toledo	Ohio
United States	Local Institution - 0043	Towson	Maryland
United States	Layrek Clinical Research	Tulsa	Oklahoma
United States	Medstar Georgetown University Hospital	Washington	District of Columbia
United States	Local Institution - 0412	Weston	Florida
United States	Accellacare US Inc. of Wilmington	Wilmington	North Carolina
United States	Southeastern Research Center	Winston-Salem	North Carolina
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Puerto Rico,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that experience spontaneous syncopal events	Cohort 1	At approximately 4 weeks
Primary	Absolute change from baseline in forced vital capacity (FVC) measured in mL	Cohort 2	At Week 52
Secondary	Number of participants who discontinued treatment due to any low BP-related Adverse Events	Cohort 1	Up to approximately 4 weeks
Secondary	Disease progression	Cohort 2; Disease progression will be measured by the time to first disease progression event in at least 1 of the following parameters: Absolute percent predicted forced vital capacity (ppFVC) decline of = 10% from baseline; Acute exacerbation of pulmonary fibrosis; Respiratory-related hospitalization; All-cause mortality	Up to approximately 4 years
Secondary	Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score	Cohort 2	At Week 52 and up to approximately 3 years
Secondary	Change from baseline in L-PF dyspnea domain score	Cohort 2	At Week 52 and up to approximately 4 years
Secondary	Change from baseline in walking distance measured in 6-minute walk test (6MWT)	Cohort 2	At Week 52
Secondary	Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first Respiratory-related hospitalization, or all-cause mortality	Cohort 2	Up to approximately 4 years
Secondary	Time to absolute percent ppFVC decline of = 10% from baseline	Cohort 2	Up to approximately 4 years
Secondary	Time to first acute exacerbation of pulmonary fibrosis	Cohort 2	Up to approximately 4 years
Secondary	Time to first Respiratory-related hospitalization	Cohort 2	Up to approximately 4 years
Secondary	Time to first pulmonary fibrosis-related hospitalization	Cohort 2	Up to approximately 4 years
Secondary	Time to all-cause mortality	Cohort 2	Up to approximately 4 years
Secondary	Change from baseline in L-PF fatigue domain score	Cohort 2	At Week 52 and up to approximately 3 years
Secondary	Change from baseline in L-PF impacts module score	Cohort 2	At Week 52 and up to approximately 3 years
Secondary	Change from baseline in cough numeric rating scale (NRS)	Cohort 2	At Week 52 and up to approximately 3 years
Secondary	Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score	Cohort 2	At Week 52
Secondary	Change from baseline in EQ-5D-5L visual analog scale score	Cohort 2	At Week 52
Secondary	Rate of decline from baseline in FVC (mL)	Cohort 2	At Week 52
Secondary	Rate of decline in ppFVC from baseline	Cohort 2	At Week 52
Secondary	Change in ppFVC from baseline	Cohort 2	At Week 52
Secondary	Proportion of participants with absolute decline in ppFVC =10%	Cohort 2	At Week 52
Secondary	Proportion of participants with relative decline in ppFVC =10%	Cohort 2	At Week 52
Secondary	Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)	Cohort 2	At Week 52
Secondary	Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline	Cohort 2	At Week 52
Secondary	Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)	Cohort 2	At Week 52
Secondary	Number of participants with Adverse Events (AEs)	Cohort 2	Up to 28 days after last dose
Secondary	Number of participants with Serious AEs (SAEs)	Cohort 2	Up to 28 days after last dose
Secondary	Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)	Cohort 2	Up to 28 days after last dose
Secondary	Number of participants with AEs related to IMP	Cohort 2	Up to 28 days after last dose
Secondary	Number of treatment-emergent deaths	Cohort 2	Up to 28 days after last dose
Secondary	Number of participants with clinical laboratory abnormalities	Cohort 2	Up to 28 days after last dose
Secondary	Number of participants with electrocardiogram (ECG) abnormalities	Cohorts 1 and 2	Up to 28 days after last dose
Secondary	Number of participants with vital sign abnormalities	Cohorts 1 and 2	Up to 28 days after last dose
Secondary	Number of participants with physical examination abnormalities	Cohort 1	Up to 28 days after last dose

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting