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    Clinical Trial Results:
    A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure

    Summary
    EudraCT number
    		 2019-004186-40
    Trial protocol
    		 GB   NL   GR   PL  
    Global end of trial date
    19 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2022
    First version publication date
    22 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CV019-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To establish safety & tolerability of BMS-986259 when initiated in-hospital in participants stabilized after an admission for ADHF
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Poland: 13
    Worldwide total number of subjects
    25
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    14
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 25 participants were randomized and treated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching BMS-986259
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching BMS-986259
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 mL QD for 14 days

    Arm title
    		 BMS-986259 3 mg
    Arm description
    		 BMS-986259 administered subcutaneously QD for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986259
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 mg QD for 14 days

    Number of subjects in period 1
    		Placebo BMS-986259 3 mg
    Started
    13
    12
    Completed
    10
    9
    Not completed
    3
    3
         Participant withdrew consent
    1
    -
         Adverse event, non-fatal
    2
    2
         Other reasons
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching BMS-986259

    Reporting group title
    BMS-986259 3 mg
    Reporting group description
    		 BMS-986259 administered subcutaneously QD for 14 days

    Reporting group values
    		 Placebo BMS-986259 3 mg Total
    Number of subjects
    		 13 12 25
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 4 6 10
        >=65 years
    		 9 6 15
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 65.1 ( 12.18 ) 63.1 ( 15.65 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 4 3 7
        Male
    		 9 9 18
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 13 12 25
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching BMS-986259

    Reporting group title
    BMS-986259 3 mg
    Reporting group description
    		 BMS-986259 administered subcutaneously QD for 14 days

    Primary: Percentage of Participants Experiencing Clinically Relevant Hypotension

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    End point title
    		 Percentage of Participants Experiencing Clinically Relevant Hypotension [1]
    End point description
    Clinically Relevant Hypotension is defined as any of the following: - Supine Systolic Blood Pressure (SBP) <85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension - Supine SBP <90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc).
    End point type
    Primary
    End point timeframe
    From first dose to 30 days following first dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were performed for this endpoint.
    End point values
    		 Placebo BMS-986259 3 mg
    Number of subjects analysed
    13
    12
    Units: Percent of participants
        number (not applicable)
    15.4
    16.7
    No statistical analyses for this end point

    Secondary: Maximum Observed Serum Concentration (Cmax)

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    End point title
    		 Maximum Observed Serum Concentration (Cmax) [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 5 of study treatment
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Values can be reported only for participants who received study drug.
    End point values
    		 BMS-986259 3 mg
    Number of subjects analysed
    12
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Day 1
    105 ( 49 )
        Day 5
    268 ( 31 )
    No statistical analyses for this end point

    Secondary: Time of Maximum Observed Serum Concentration (Tmax)

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    End point title
    		 Time of Maximum Observed Serum Concentration (Tmax) [3]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 5 of study treatment
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Values can be reported only for participants who received study drug.
    End point values
    		 BMS-986259 3 mg
    Number of subjects analysed
    12
    Units: Hours
    median (full range (min-max))
        Day 1
    11.0 (7.00 to 23.3)
        Day 5
    7.97 (5.00 to 24.0)
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))

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    End point title
    		 Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) [4]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 5 of study treatment
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Values can be reported only for participants who received study drug.
    End point values
    		 BMS-986259 3 mg
    Number of subjects analysed
    12
    Units: h*ng/mL
    geometric mean (geometric coefficient of variation)
        Day 1
    1778 ( 40 )
        Day 5
    5156 ( 36 )
    No statistical analyses for this end point

    Secondary: Trough Concentration (Ctrough)

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    End point title
    		 Trough Concentration (Ctrough) [5]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 2 through Day 14 of study treatment
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Values can be reported only for participants who received study drug.
    End point values
    		 BMS-986259 3 mg
    Number of subjects analysed
    11
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Day 2
    79.9 ( 36.0 )
        Day 3
    145 ( 32.3 )
        Day 4
    181 ( 28.9 )
        Day 5
    185 ( 32.4 )
        Day 6
    210 ( 27.3 )
        Day 7
    260 ( 41.3 )
        Day 8
    226 ( 69.4 )
        Day 9
    252 ( 48.1 )
        Day 10
    259 ( 49.7 )
        Day 12
    229 ( 22.9 )
        Day 13
    248 ( 50.5 )
        Day 14
    246 ( 7.53 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    BMS986259 3 mg
    Reporting group description
    		 BMS-986259 administered subcutaneously QD for 14 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching BMS-986259

    Serious adverse events
    		 BMS986259 3 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 12 (16.67%)
    5 / 13 (38.46%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BMS986259 3 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 12 (66.67%)
    3 / 13 (23.08%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Procedural haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    2
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Haemoconcentration
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Genital haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Oct 2020
    Added safety measures in response to the Coronavirus disease 2019 (COVID-19) pandemic

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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