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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06003426




Registration number
Help: Registration number
NCT06003426
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
15/08/2023
Date registered
Help: Date registered
22/08/2023
Date last updated
Help: Date last updated
29/09/2025

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
Scientific 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
Secondary ID [1] 0 0
IM027-068
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986278
Treatment: Drugs - BMS-986278 Placebo

Experimental: BMS-986278 Dose 1 -

Experimental: BMS-986278 Dose 2 -

Placebo comparator: BMS-986278 Placebo -


Treatment: Drugs: BMS-986278
Specified dose on specified days

Treatment: Drugs: BMS-986278 Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants that experience spontaneous syncopal events
Timepoint [1] 0 0
At approximately 4 weeks
Primary outcome [2] 0 0
Absolute change from baseline in forced vital capacity (FVC) measured in mL
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [1] 0 0
Number of participants who discontinued treatment due to any low BP-related Adverse Events
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Disease progression
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
Change from baseline in L-PF dyspnea domain score
Timepoint [4] 0 0
Up to Week 52
Secondary outcome [5] 0 0
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
Timepoint [5] 0 0
Up to Week 52
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Time to absolute percent ppFVC decline of = 10% from baseline
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Time to first acute exacerbation of pulmonary fibrosis
Timepoint [8] 0 0
Up to approximately 3 years
Secondary outcome [9] 0 0
Time to first Respiratory-related hospitalization
Timepoint [9] 0 0
Up to approximately 3 years
Secondary outcome [10] 0 0
Time to first pulmonary fibrosis-related hospitalization
Timepoint [10] 0 0
Up to approximately 3 years
Secondary outcome [11] 0 0
Time to death
Timepoint [11] 0 0
Up to approximately 3 years
Secondary outcome [12] 0 0
Change from baseline in L-PF fatigue domain score
Timepoint [12] 0 0
Up to Week 52
Secondary outcome [13] 0 0
Change from baseline in L-PF impacts module score
Timepoint [13] 0 0
Up to Week 52
Secondary outcome [14] 0 0
Change from baseline in cough numeric rating scale (NRS)
Timepoint [14] 0 0
Up to Week 52
Secondary outcome [15] 0 0
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
Timepoint [15] 0 0
Up to Week 52
Secondary outcome [16] 0 0
Change from baseline in EQ-5D-5L visual analog scale score
Timepoint [16] 0 0
Up to Week 52
Secondary outcome [17] 0 0
Rate of decline from baseline in FVC (mL)
Timepoint [17] 0 0
Up to Week 52
Secondary outcome [18] 0 0
Rate of decline in ppFVC from baseline
Timepoint [18] 0 0
Up to Week 52
Secondary outcome [19] 0 0
Change in ppFVC from baseline
Timepoint [19] 0 0
Up to Week 52
Secondary outcome [20] 0 0
Proportion of participants with absolute decline in ppFVC =10%
Timepoint [20] 0 0
Up to Week 52
Secondary outcome [21] 0 0
Proportion of participants with relative decline in ppFVC =10%
Timepoint [21] 0 0
Up to Week 52
Secondary outcome [22] 0 0
Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)
Timepoint [22] 0 0
Up to Week 52
Secondary outcome [23] 0 0
Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline
Timepoint [23] 0 0
Up to Week 52
Secondary outcome [24] 0 0
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
Timepoint [24] 0 0
Up to Week 52
Secondary outcome [25] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [25] 0 0
Up to 28 days after last dose
Secondary outcome [26] 0 0
Number of participants with Serious AEs (SAEs)
Timepoint [26] 0 0
Up to 28 days after last dose
Secondary outcome [27] 0 0
Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)
Timepoint [27] 0 0
Up to 28 days after last dose
Secondary outcome [28] 0 0
Number of participants with AEs related to IMP
Timepoint [28] 0 0
Up to 28 days after last dose
Secondary outcome [29] 0 0
Number of treatment-emergent deaths
Timepoint [29] 0 0
Up to 28 days after last dose
Secondary outcome [30] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [30] 0 0
Up to 28 days after last dose
Secondary outcome [31] 0 0
Number of participants with electrocardiogram (ECG) abnormalities
Timepoint [31] 0 0
Up to 28 days after last dose
Secondary outcome [32] 0 0
Number of participants with vital sign abnormalities
Timepoint [32] 0 0
Up to 28 days after last dose
Secondary outcome [33] 0 0
Number of participants with physical examination abnormalities
Timepoint [33] 0 0
Up to 28 days after last dose

Eligibility
Key inclusion criteria
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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/10/2026
Actual
Sample size
Target
Accrual to date
Final
1255
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0209 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0239 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0210 - Brisbane
Recruitment hospital [4] 0 0
Local Institution - 0229 - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - 0421 - South Brisbane
Recruitment hospital [6] 0 0
Local Institution - 0309 - Adelaide
Recruitment hospital [7] 0 0
Local Institution - 0443 - Box Hill
Recruitment hospital [8] 0 0
Local Institution - 0420 - Frankston
Recruitment hospital [9] 0 0
Local Institution - 0419 - Murdoch
Recruitment hospital [10] 0 0
Local Institution - 0385 - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4032 - Brisbane
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
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State/province [187] 0 0
Minatoku
Country [188] 0 0
Japan
State/province [188] 0 0
Nagoya
Country [189] 0 0
Japan
State/province [189] 0 0
Seto
Country [190] 0 0
Japan
State/province [190] 0 0
Shinjyu-Ku
Country [191] 0 0
Japan
State/province [191] 0 0
Tenri-Shi
Country [192] 0 0
Japan
State/province [192] 0 0
Yokohama
Country [193] 0 0
Japan
State/province [193] 0 0
Yoshida-Gun
Country [194] 0 0
Mexico
State/province [194] 0 0
Edo de Mexico
Country [195] 0 0
Mexico
State/province [195] 0 0
Michoacán
Country [196] 0 0
Mexico
State/province [196] 0 0
Oaxaca
Country [197] 0 0
Netherlands
State/province [197] 0 0
South Holland
Country [198] 0 0
Netherlands
State/province [198] 0 0
Amsterdam
Country [199] 0 0
Netherlands
State/province [199] 0 0
Heerlen
Country [200] 0 0
Netherlands
State/province [200] 0 0
Nieuwegein
Country [201] 0 0
Peru
State/province [201] 0 0
LIM
Country [202] 0 0
Peru
State/province [202] 0 0
Lima
Country [203] 0 0
Poland
State/province [203] 0 0
Kuyavian-Pomeranian Voivodeship
Country [204] 0 0
Poland
State/province [204] 0 0
Podlaskie Voivodeship
Country [205] 0 0
Poland
State/province [205] 0 0
Pomeranian Voivodeship
Country [206] 0 0
Poland
State/province [206] 0 0
Warmian-Masurian Voivodeship
Country [207] 0 0
Poland
State/province [207] 0 0
Lodz
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Portugal
State/province [208] 0 0
Faro
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Portugal
State/province [209] 0 0
Lisbon
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Portugal
State/province [210] 0 0
Loures
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Portugal
State/province [211] 0 0
Porto
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Portugal
State/province [212] 0 0
Vila Nova de Gaia
Country [213] 0 0
Puerto Rico
State/province [213] 0 0
PR
Country [214] 0 0
South Korea
State/province [214] 0 0
Gyeonggi-do
Country [215] 0 0
South Korea
State/province [215] 0 0
Seoul
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South Korea
State/province [216] 0 0
Ulsan
Country [217] 0 0
South Korea
State/province [217] 0 0
Bucheon-si
Country [218] 0 0
South Korea
State/province [218] 0 0
Bucheonsi Weonmigu
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South Korea
State/province [219] 0 0
Busan
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South Korea
State/province [220] 0 0
Donggu
Country [221] 0 0
South Korea
State/province [221] 0 0
Haeundae-Gu
Country [222] 0 0
South Korea
State/province [222] 0 0
Iksansi
Country [223] 0 0
South Korea
State/province [223] 0 0
Incheon
Country [224] 0 0
South Korea
State/province [224] 0 0
Suwon, Gyeonggi-do
Country [225] 0 0
Spain
State/province [225] 0 0
CB
Country [226] 0 0
Spain
State/province [226] 0 0
C
Country [227] 0 0
Spain
State/province [227] 0 0
M
Country [228] 0 0
Spain
State/province [228] 0 0
Barcelona
Country [229] 0 0
Spain
State/province [229] 0 0
Girona
Country [230] 0 0
Spain
State/province [230] 0 0
Madrid
Country [231] 0 0
Spain
State/province [231] 0 0
Oviedo
Country [232] 0 0
Spain
State/province [232] 0 0
Pamplona
Country [233] 0 0
Switzerland
State/province [233] 0 0
Canton of Basel-City
Country [234] 0 0
Switzerland
State/province [234] 0 0
Canton of Bern
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Switzerland
State/province [235] 0 0
Canton of Geneva
Country [236] 0 0
Taiwan
State/province [236] 0 0
CHA
Country [237] 0 0
Taiwan
State/province [237] 0 0
Kao-Hsiung
Country [238] 0 0
Taiwan
State/province [238] 0 0
TXG
Country [239] 0 0
Taiwan
State/province [239] 0 0
YUN
Country [240] 0 0
Taiwan
State/province [240] 0 0
Kaohsiung City
Country [241] 0 0
Taiwan
State/province [241] 0 0
New Taipei City
Country [242] 0 0
Taiwan
State/province [242] 0 0
Taichung
Country [243] 0 0
Taiwan
State/province [243] 0 0
Taipei
Country [244] 0 0
Turkey (Türkiye)
State/province [244] 0 0
Gümüshane Province
Country [245] 0 0
Turkey (Türkiye)
State/province [245] 0 0
Ankara
Country [246] 0 0
Turkey (Türkiye)
State/province [246] 0 0
Bursa
Country [247] 0 0
Turkey (Türkiye)
State/province [247] 0 0
Izmir
Country [248] 0 0
Turkey (Türkiye)
State/province [248] 0 0
Maltepe
Country [249] 0 0
Turkey (Türkiye)
State/province [249] 0 0
Pasaport
Country [250] 0 0
Turkey (Türkiye)
State/province [250] 0 0
Topkapi
Country [251] 0 0
United Kingdom
State/province [251] 0 0
BIR
Country [252] 0 0
United Kingdom
State/province [252] 0 0
BST
Country [253] 0 0
United Kingdom
State/province [253] 0 0
Cambridgeshire
Country [254] 0 0
United Kingdom
State/province [254] 0 0
DND
Country [255] 0 0
United Kingdom
State/province [255] 0 0
EDH
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Greater London
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Oxfordshire
Country [258] 0 0
United Kingdom
State/province [258] 0 0
PTE
Country [259] 0 0
United Kingdom
State/province [259] 0 0
Yorkshire and the Humber
Country [260] 0 0
United Kingdom
State/province [260] 0 0
Birmingham
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06003426