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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04308681




Registration number
NCT04308681
Ethics application status
Date submitted
12/03/2020
Date registered
16/03/2020
Date last updated
24/10/2023

Titles & IDs
Public title
A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis
Secondary ID [1] 0 0
2019-003992-21
Secondary ID [2] 0 0
IM027-040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Other interventions - BMS-986278 Placebo
Treatment: Drugs - BMS-986278

Experimental: IPF Dose 1 + Post Treatment Follow-up or OTE - IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)

Experimental: IPF Dose 2 + Post Treatment Follow-up or OTE -

Placebo comparator: IPF Placebo + Post Treatment Follow-up or OTE -

Experimental: PF-ILD Dose 1 + Post Treatment Follow-up or OTE - PF-ILD (Progressive Fibrotic Interstitial Lung Disease)

Experimental: PF-ILD Dose 2 + Post Treatment Follow-up or OTE -

Placebo comparator: PF-ILD Placebo + Post Treatment Follow-up or OTE -


Other interventions: BMS-986278 Placebo
Specified Dose on Specified Days

Treatment: Drugs: BMS-986278
Specified Dose on Specified Days
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants
Timepoint [1] 0 0
Up to week 26
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 26 weeks
Secondary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 26 weeks
Secondary outcome [3] 0 0
Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment
Timepoint [3] 0 0
Up to 26 weeks
Secondary outcome [4] 0 0
Incidence of Treatment-Emergent Deaths
Timepoint [4] 0 0
Up to 26 weeks
Secondary outcome [5] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [5] 0 0
Up to 26 weeks
Secondary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [6] 0 0
Up to 26 weeks
Secondary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [7] 0 0
Up to 26 weeks
Secondary outcome [8] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Timepoint [8] 0 0
Up to 26 weeks
Secondary outcome [9] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Timepoint [9] 0 0
Up to 26 weeks
Secondary outcome [10] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Timepoint [10] 0 0
Up to 26 weeks
Secondary outcome [11] 0 0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Timepoint [11] 0 0
Up to 26 weeks
Secondary outcome [12] 0 0
Incidence of clinically significant changes in vital signs: Body temperature
Timepoint [12] 0 0
Up to 26 weeks
Secondary outcome [13] 0 0
Incidence of clinically significant changes in vital signs: Respiratory rate
Timepoint [13] 0 0
Up to 26 weeks
Secondary outcome [14] 0 0
Incidence of clinically significant changes in vital signs: Blood pressure
Timepoint [14] 0 0
Up to 26 weeks
Secondary outcome [15] 0 0
Incidence of clinically significant changes in vital signs: Heart rate
Timepoint [15] 0 0
Up to 26 weeks
Secondary outcome [16] 0 0
Incidence of clinically significant changes in physical examination findings
Timepoint [16] 0 0
Up to 26 weeks
Secondary outcome [17] 0 0
Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants
Timepoint [17] 0 0
Up to 26 weeks
Secondary outcome [18] 0 0
Proportion of participants with = 10% absolute decline in ppFVC (%)
Timepoint [18] 0 0
At weeks 4, 8, 12, 16, 20, and 26
Secondary outcome [19] 0 0
Proportion of participants with > 0% change in ppFVC
Timepoint [19] 0 0
At weeks 4, 8, 12, 16, 20, and 26
Secondary outcome [20] 0 0
Time to first acute exacerbation
Timepoint [20] 0 0
Up to 26 weeks
Secondary outcome [21] 0 0
Time to first = 10% absolute decline in ppFVC (%)
Timepoint [21] 0 0
Up to 26 weeks
Secondary outcome [22] 0 0
Absolute change in FVC (mL) from baseline to Week 26
Timepoint [22] 0 0
Up to 26 weeks
Secondary outcome [23] 0 0
Absolute change in ppFVC (%) from baseline to Week 26
Timepoint [23] 0 0
Up to 26 weeks
Secondary outcome [24] 0 0
Absolute change in single-breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26
Timepoint [24] 0 0
Up to 26 weeks
Secondary outcome [25] 0 0
Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26
Timepoint [25] 0 0
Up to 26 weeks
Secondary outcome [26] 0 0
Change in walking endurance/distance from baseline at Week 26 as measured using the 6-Minute Walk Test (6MWT)
Timepoint [26] 0 0
Up to 26 weeks
Secondary outcome [27] 0 0
Proportion of participants with acute exacerbations of lung fibrosis
Timepoint [27] 0 0
Up to 26 weeks
Secondary outcome [28] 0 0
Maximum observed concentration (Cmax) of BMS-986278
Timepoint [28] 0 0
Day 1 and Week 4
Secondary outcome [29] 0 0
Time of maximum observed concentration (Tmax) of BMS-986278
Timepoint [29] 0 0
Day 1 and Week 4
Secondary outcome [30] 0 0
Area under the plasma concentration-time curve form time 0 to 8 hours post dose of BMS-986278 (AUC(0-8))
Timepoint [30] 0 0
Day 1 and Week 4
Secondary outcome [31] 0 0
Trough observed plasma concentration (Ctrough) of BMS-986278
Timepoint [31] 0 0
Week 4 and Week 12

Eligibility
Key inclusion criteria
For the idiopathic pulmonary fibrosis (IPF) Cohort

* Diagnosis of IPF within 7 years of screening
* Female and males = 40 years of age

For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort

* Evidence of progressive ILD within the 24 months before screening
* Female and male = 21 years of age.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women of childbearing potential (WOCBP)
* Active Smokers
* Current malignancy or previous malignancy up to 5 years prior to screening
* History of allergy to BMS-986278 or related compounds

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2023
Sample size
Target
Accrual to date
Final
399
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0045 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0025 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0026 - Brisbane
Recruitment hospital [4] 0 0
Local Institution - 0046 - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - 0022 - Adelaide
Recruitment hospital [6] 0 0
Local Institution - 0023 - Heidelberg
Recruitment hospital [7] 0 0
Local Institution - 0021 - Murdoch
Recruitment hospital [8] 0 0
Local Institution - 0044 - 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
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Distrito Federal
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa FE
Country [18] 0 0
Argentina
State/province [18] 0 0
Tucuman
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos AIres
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Mendoza
Country [22] 0 0
Belgium
State/province [22] 0 0
Brussels
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Belgium
State/province [24] 0 0
Liège
Country [25] 0 0
Brazil
State/province [25] 0 0
RIO Grande DO SUL
Country [26] 0 0
Brazil
State/province [26] 0 0
SAO Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Chile
State/province [31] 0 0
Maule
Country [32] 0 0
Chile
State/province [32] 0 0
Valparaiso
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Hubei
Country [35] 0 0
China
State/province [35] 0 0
Shanghai
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France
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Bobigny
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France
State/province [37] 0 0
Bron
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France
State/province [38] 0 0
Dijon
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France
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Marseille
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France
State/province [40] 0 0
Paris
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France
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Rennes
Country [42] 0 0
France
State/province [42] 0 0
Toulouse
Country [43] 0 0
Germany
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Niedersachsen
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Germany
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Essen
Country [45] 0 0
Germany
State/province [45] 0 0
Freiburg
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Germany
State/province [46] 0 0
Grosshansdorf
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Germany
State/province [47] 0 0
Heidelberg
Country [48] 0 0
Germany
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Munich
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Germany
State/province [49] 0 0
Stuttgart
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Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
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Petah Tikva
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Israel
State/province [53] 0 0
Ramat Gan
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Israel
State/province [54] 0 0
Tel Aviv
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Italy
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Catania
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Italy
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Modena
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Italy
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Monza
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Italy
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Roma
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Japan
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Aichi
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Japan
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Fukushima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Osaka
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Shimane
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Kumamoto
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Japan
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Nagasaki
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Japan
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Saitama
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Nuevo Leon
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Mexico
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Nuevo LEON
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Mexico
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Oaxaca
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Spain
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Barcelona
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Spain
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L'Hospitalet de Llobregat
Country [78] 0 0
Spain
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Madrid
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Spain
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Marbella Málaga
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Spain
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Pozuelo de Alarcon
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Spain
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Santander
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Taiwan
State/province [82] 0 0
Kaohsiung
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Taiwan
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Taipei
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United Kingdom
State/province [84] 0 0
Cambridge
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Edinburgh
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.
Trial website
https://clinicaltrials.gov/study/NCT04308681
Trial related presentations / publications
Corte TJ, Lancaster L, Swigris JJ, Maher TM, Goldin JG, Palmer SM, Suda T, Ogura T, Minnich A, Zhan X, Tirucherai GS, Elpers B, Xiao H, Watanabe H, Smith RA, Charles ED, Fischer A. Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrotic interstitial lung disease (PF-ILD). BMJ Open Respir Res. 2021 Dec;8(1):e001026. doi: 10.1136/bmjresp-2021-001026.
Cheng PTW, Kaltenbach RF 3rd, Zhang H, Shi J, Tao S, Li J, Kennedy LJ, Walker SJ, Shi Y, Wang Y, Dhanusu S, Reddigunta R, Kumaravel S, Jusuf S, Smith D, Krishnananthan S, Li J, Wang T, Heiry R, Sum CS, Kalinowski SS, Hung CP, Chu CH, Azzara AV, Ziegler M, Burns L, Zinker BA, Boehm S, Taylor J, Sapuppo J, Mosure K, Everlof G, Guarino V, Zhang L, Yang Y, Ruan Q, Xu C, Apedo A, Traeger SC, Cvijic ME, Lentz KA, Tirucherai G, Sivaraman L, Robl J, Ellsworth BA, Rosen G, Gordon DA, Soars MG, Gill M, Murphy BJ. Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA1) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases. J Med Chem. 2021 Nov 11;64(21):15549-15581. doi: 10.1021/acs.jmedchem.1c01256. Epub 2021 Oct 28.
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04308681