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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
NCT06003426
Ethics application status
Date submitted
15/08/2023
Date registered
22/08/2023

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
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

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
At 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 4 weeks
Secondary outcome [2] 0 0
Disease progression
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [3] 0 0
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
Timepoint [3] 0 0
At Week 52 and up to approximately 3 years
Secondary outcome [4] 0 0
Change from baseline in L-PF dyspnea domain score
Timepoint [4] 0 0
At Week 52 and up to approximately 4 years
Secondary outcome [5] 0 0
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
Timepoint [5] 0 0
At 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 4 years
Secondary outcome [7] 0 0
Time to absolute percent ppFVC decline of = 10% from baseline
Timepoint [7] 0 0
Up to approximately 4 years
Secondary outcome [8] 0 0
Time to first acute exacerbation of pulmonary fibrosis
Timepoint [8] 0 0
Up to approximately 4 years
Secondary outcome [9] 0 0
Time to first Respiratory-related hospitalization
Timepoint [9] 0 0
Up to approximately 4 years
Secondary outcome [10] 0 0
Time to first pulmonary fibrosis-related hospitalization
Timepoint [10] 0 0
Up to approximately 4 years
Secondary outcome [11] 0 0
Time to all-cause mortality
Timepoint [11] 0 0
Up to approximately 4 years
Secondary outcome [12] 0 0
Change from baseline in L-PF fatigue domain score
Timepoint [12] 0 0
At Week 52 and up to approximately 3 years
Secondary outcome [13] 0 0
Change from baseline in L-PF impacts module score
Timepoint [13] 0 0
At Week 52 and up to approximately 3 years
Secondary outcome [14] 0 0
Change from baseline in cough numeric rating scale (NRS)
Timepoint [14] 0 0
At Week 52 and up to approximately 3 years
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
At Week 52
Secondary outcome [16] 0 0
Change from baseline in EQ-5D-5L visual analog scale score
Timepoint [16] 0 0
At Week 52
Secondary outcome [17] 0 0
Rate of decline from baseline in FVC (mL)
Timepoint [17] 0 0
At Week 52
Secondary outcome [18] 0 0
Rate of decline in ppFVC from baseline
Timepoint [18] 0 0
At Week 52
Secondary outcome [19] 0 0
Change in ppFVC from baseline
Timepoint [19] 0 0
At Week 52
Secondary outcome [20] 0 0
Proportion of participants with absolute decline in ppFVC =10%
Timepoint [20] 0 0
At Week 52
Secondary outcome [21] 0 0
Proportion of participants with relative decline in ppFVC =10%
Timepoint [21] 0 0
At 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
At 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
At 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
At 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 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.

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
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
1185
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0293 - Darlinghurst
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0474 - Chermside
Recruitment hospital [6] 0 0
Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) - Greenslopes
Recruitment hospital [7] 0 0
Local Institution - 0421 - South Brisbane
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Eastern Health - Box Hill
Recruitment hospital [10] 0 0
Peninsula Health - Frankston Hospital - Frankston
Recruitment hospital [11] 0 0
Local Institution - 0357 - Heidelberg
Recruitment hospital [12] 0 0
Local Institution - 0253 - Melbourne
Recruitment hospital [13] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [14] 0 0
Institute for Respiratory Health - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3199 - Frankston
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
6150 - Murdoch
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment outside Australia
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Arizona
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RM
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Italy
State/province [179] 0 0
TS
Country [180] 0 0
Italy
State/province [180] 0 0
Ancona
Country [181] 0 0
Italy
State/province [181] 0 0
Bergamo
Country [182] 0 0
Italy
State/province [182] 0 0
Foggia
Country [183] 0 0
Italy
State/province [183] 0 0
Forli
Country [184] 0 0
Italy
State/province [184] 0 0
Milan
Country [185] 0 0
Italy
State/province [185] 0 0
Monza
Country [186] 0 0
Italy
State/province [186] 0 0
Naples
Country [187] 0 0
Italy
State/province [187] 0 0
Napoli
Country [188] 0 0
Italy
State/province [188] 0 0
Palermo
Country [189] 0 0
Italy
State/province [189] 0 0
Pavia
Country [190] 0 0
Italy
State/province [190] 0 0
Sassari
Country [191] 0 0
Italy
State/province [191] 0 0
Siena
Country [192] 0 0
Japan
State/province [192] 0 0
Chiba
Country [193] 0 0
Japan
State/province [193] 0 0
Fukuoka-Ken
Country [194] 0 0
Japan
State/province [194] 0 0
Fukuoka
Country [195] 0 0
Japan
State/province [195] 0 0
Fukushima
Country [196] 0 0
Japan
State/province [196] 0 0
Gunma
Country [197] 0 0
Japan
State/province [197] 0 0
Hirohima-ken
Country [198] 0 0
Japan
State/province [198] 0 0
Hokkaido
Country [199] 0 0
Japan
State/province [199] 0 0
Hyogo
Country [200] 0 0
Japan
State/province [200] 0 0
Mie
Country [201] 0 0
Japan
State/province [201] 0 0
NGS
Country [202] 0 0
Japan
State/province [202] 0 0
Osaka
Country [203] 0 0
Japan
State/province [203] 0 0
OSK
Country [204] 0 0
Japan
State/province [204] 0 0
TKY
Country [205] 0 0
Japan
State/province [205] 0 0
Tochigi
Country [206] 0 0
Japan
State/province [206] 0 0
Tokushima
Country [207] 0 0
Japan
State/province [207] 0 0
Tokyo-to
Country [208] 0 0
Japan
State/province [208] 0 0
Tokyo
Country [209] 0 0
Japan
State/province [209] 0 0
Ginowan-Shi
Country [210] 0 0
Japan
State/province [210] 0 0
Hamamatsu-shi
Country [211] 0 0
Japan
State/province [211] 0 0
Himeji-Shi
Country [212] 0 0
Japan
State/province [212] 0 0
Iizuka-shi
Country [213] 0 0
Japan
State/province [213] 0 0
Izumo-Shi
Country [214] 0 0
Japan
State/province [214] 0 0
Kamogawa-Shi
Country [215] 0 0
Japan
State/province [215] 0 0
Kumamoto-Shi
Country [216] 0 0
Japan
State/province [216] 0 0
Minato-Ku
Country [217] 0 0
Japan
State/province [217] 0 0
Minato-ku
Country [218] 0 0
Japan
State/province [218] 0 0
Nagoya
Country [219] 0 0
Japan
State/province [219] 0 0
Seto
Country [220] 0 0
Japan
State/province [220] 0 0
Shinjuku-Ku
Country [221] 0 0
Japan
State/province [221] 0 0
Shinjyu-Ku
Country [222] 0 0
Japan
State/province [222] 0 0
Tenri-Shi
Country [223] 0 0
Japan
State/province [223] 0 0
Uruma-shi
Country [224] 0 0
Japan
State/province [224] 0 0
Yokohama-Shi
Country [225] 0 0
Japan
State/province [225] 0 0
Yoshida-Gun
Country [226] 0 0
Korea, Republic of
State/province [226] 0 0
Busan
Country [227] 0 0
Korea, Republic of
State/province [227] 0 0
Gyeonggi-Do
Country [228] 0 0
Korea, Republic of
State/province [228] 0 0
Seoul
Country [229] 0 0
Korea, Republic of
State/province [229] 0 0
Ulsan
Country [230] 0 0
Korea, Republic of
State/province [230] 0 0
Bucheon-Si
Country [231] 0 0
Korea, Republic of
State/province [231] 0 0
Bucheonsi Weonmigu
Country [232] 0 0
Korea, Republic of
State/province [232] 0 0
Deogyang-Gu, Goyang-Si
Country [233] 0 0
Korea, Republic of
State/province [233] 0 0
Dong-Gu
Country [234] 0 0
Korea, Republic of
State/province [234] 0 0
Gyeonggi-do
Country [235] 0 0
Korea, Republic of
State/province [235] 0 0
Haeundae-Gu
Country [236] 0 0
Korea, Republic of
State/province [236] 0 0
Iksansi
Country [237] 0 0
Korea, Republic of
State/province [237] 0 0
Incheon
Country [238] 0 0
Korea, Republic of
State/province [238] 0 0
Suwon, Gyeonggi-do
Country [239] 0 0
Malaysia
State/province [239] 0 0
Selangor Darul Ehsan
Country [240] 0 0
Malaysia
State/province [240] 0 0
Wilayah Persekutuan Kuala Lumpur
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Malaysia
State/province [241] 0 0
Kuching
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Mexico
State/province [242] 0 0
AGU
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Mexico
State/province [243] 0 0
CHH
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Mexico
State/province [244] 0 0
DIF
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Mexico
State/province [245] 0 0
Jalisco
Country [246] 0 0
Mexico
State/province [246] 0 0
JAL
Country [247] 0 0
Mexico
State/province [247] 0 0
MIC
Country [248] 0 0
Mexico
State/province [248] 0 0
Nuevo Leon
Country [249] 0 0
Mexico
State/province [249] 0 0
OAX
Country [250] 0 0
Mexico
State/province [250] 0 0
VER
Country [251] 0 0
Mexico
State/province [251] 0 0
YUC
Country [252] 0 0
Mexico
State/province [252] 0 0
Chihuahua
Country [253] 0 0
Mexico
State/province [253] 0 0
Guadalajara
Country [254] 0 0
Mexico
State/province [254] 0 0
Metepec
Country [255] 0 0
Mexico
State/province [255] 0 0
Mexico City
Country [256] 0 0
Netherlands
State/province [256] 0 0
South Holland
Country [257] 0 0
Netherlands
State/province [257] 0 0
ZH
Country [258] 0 0
Netherlands
State/province [258] 0 0
Amsterdam
Country [259] 0 0
Netherlands
State/province [259] 0 0
Heerlen
Country [260] 0 0
Netherlands
State/province [260] 0 0
Nieuwegein
Country [261] 0 0
Peru
State/province [261] 0 0
LIM
Country [262] 0 0
Peru
State/province [262] 0 0
PIU
Country [263] 0 0
Peru
State/province [263] 0 0
Lima
Country [264] 0 0
Poland
State/province [264] 0 0
KP
Country [265] 0 0
Poland
State/province [265] 0 0
MA
Country [266] 0 0
Poland
State/province [266] 0 0
PD
Country [267] 0 0
Poland
State/province [267] 0 0
Pomorskie
Country [268] 0 0
Poland
State/province [268] 0 0
WN
Country [269] 0 0
Poland
State/province [269] 0 0
Bedzin
Country [270] 0 0
Poland
State/province [270] 0 0
Katowice
Country [271] 0 0
Poland
State/province [271] 0 0
Lodz
Country [272] 0 0
Portugal
State/province [272] 0 0
Braga
Country [273] 0 0
Portugal
State/province [273] 0 0
Faro
Country [274] 0 0
Portugal
State/province [274] 0 0
Lisboa
Country [275] 0 0
Portugal
State/province [275] 0 0
Loures
Country [276] 0 0
Portugal
State/province [276] 0 0
Porto
Country [277] 0 0
Portugal
State/province [277] 0 0
Vila Nova de Gaia
Country [278] 0 0
Puerto Rico
State/province [278] 0 0
Guaynabo
Country [279] 0 0
Spain
State/province [279] 0 0
Barcelona
Country [280] 0 0
Spain
State/province [280] 0 0
CB
Country [281] 0 0
Spain
State/province [281] 0 0
Comunidad Valencia
Country [282] 0 0
Spain
State/province [282] 0 0
C
Country [283] 0 0
Spain
State/province [283] 0 0
M
Country [284] 0 0
Spain
State/province [284] 0 0
Girona
Country [285] 0 0
Spain
State/province [285] 0 0
Madrid
Country [286] 0 0
Spain
State/province [286] 0 0
Oviedo
Country [287] 0 0
Spain
State/province [287] 0 0
Pamplona
Country [288] 0 0
Switzerland
State/province [288] 0 0
BE
Country [289] 0 0
Switzerland
State/province [289] 0 0
BS
Country [290] 0 0
Switzerland
State/province [290] 0 0
Geneve
Country [291] 0 0
Switzerland
State/province [291] 0 0
St Gallen
Country [292] 0 0
Taiwan
State/province [292] 0 0
CHA
Country [293] 0 0
Taiwan
State/province [293] 0 0
Kao-Hsiung
Country [294] 0 0
Taiwan
State/province [294] 0 0
TXG
Country [295] 0 0
Taiwan
State/province [295] 0 0
YUN
Country [296] 0 0
Taiwan
State/province [296] 0 0
Kaohsiung
Country [297] 0 0
Taiwan
State/province [297] 0 0
New Taipei City
Country [298] 0 0
Taiwan
State/province [298] 0 0
Taichung
Country [299] 0 0
Taiwan
State/province [299] 0 0
Taipei City
Country [300] 0 0
Taiwan
State/province [300] 0 0
Taipei
Country [301] 0 0
Thailand
State/province [301] 0 0
Bangkok
Country [302] 0 0
Thailand
State/province [302] 0 0
Chiang Mai
Country [303] 0 0
Thailand
State/province [303] 0 0
Khon Kaen
Country [304] 0 0
Thailand
State/province [304] 0 0
Songkla
Country [305] 0 0
Turkey
State/province [305] 0 0
Adana
Country [306] 0 0
Turkey
State/province [306] 0 0
Ankara
Country [307] 0 0
Turkey
State/province [307] 0 0
Bursa
Country [308] 0 0
Turkey
State/province [308] 0 0
Guemueshane
Country [309] 0 0
Turkey
State/province [309] 0 0
Izmir
Country [310] 0 0
Turkey
State/province [310] 0 0
Keçiören/Ankara
Country [311] 0 0
Turkey
State/province [311] 0 0
Maltepe
Country [312] 0 0
Turkey
State/province [312] 0 0
Pasaport
Country [313] 0 0
Turkey
State/province [313] 0 0
Topkapi
Country [314] 0 0
United Kingdom
State/province [314] 0 0
BIR
Country [315] 0 0
United Kingdom
State/province [315] 0 0
BST
Country [316] 0 0
United Kingdom
State/province [316] 0 0
Cambridgeshire
Country [317] 0 0
United Kingdom
State/province [317] 0 0
DND
Country [318] 0 0
United Kingdom
State/province [318] 0 0
EDH
Country [319] 0 0
United Kingdom
State/province [319] 0 0
Greater London
Country [320] 0 0
United Kingdom
State/province [320] 0 0
Hampshire
Country [321] 0 0
United Kingdom
State/province [321] 0 0
Nottinghamshire
Country [322] 0 0
United Kingdom
State/province [322] 0 0
Oxfordshire
Country [323] 0 0
United Kingdom
State/province [323] 0 0
PTE
Country [324] 0 0
United Kingdom
State/province [324] 0 0
South West
Country [325] 0 0
United Kingdom
State/province [325] 0 0
STY
Country [326] 0 0
United Kingdom
State/province [326] 0 0
Yorkshire And The Humber
Country [327] 0 0
United Kingdom
State/province [327] 0 0
Birmingham
Country [328] 0 0
United Kingdom
State/province [328] 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
Clinical.Trials@bms.com
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