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    Clinical Trial Results:
    A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India (RAMAN)

    Summary
    EudraCT number
    		 2020-005111-51
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2020
    First version publication date
    04 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20170199
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03403374
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    27 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to characterize the safety and tolerability in homozygous familial hypercholesterolemia (HoFH) patients in India exposed to 12 weeks of evolocumab (Repatha).
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP), Declaration of Helsinki, and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines. The investigator or his/her designee informed the subject of all aspects pertaining to the subject’s participation in the study before any screening procedures were performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 2018
    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
    India: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    0
    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)
    13
    Adults (18-64 years)
    16
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 10 study centers in India. The first participant was enrolled on 04 August 2018 and the last participant was enrolled on 29 August 2019.

    Pre-assignment
    Screening details
    		 This study included a screening period of up to 4 weeks.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Evolocumab
    Arm description
    		 Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).
    Arm type
    		 Experimental

    Investigational medicinal product name
    evolocumab
    Investigational medicinal product code
    AMG 145
    Other name
    Repatha® EvoMab
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by SC injection via autoinjector (AI)/pen

    Number of subjects in period 1
    		Evolocumab
    Started
    30
    Completed
    29
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Evolocumab
    Reporting group description
    		 Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).

    Reporting group values
    		 Evolocumab Total
    Number of subjects
    		 30 30
    Age Categorical
    Units: participants
        Adolescents (12 - 17 years old)
    		 13 13
        Adults (18 - 64 years old)
    		 16 16
        Adults (65 - 84 years old)
    		 1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.2 ( 13.1 ) -
    Sex: Female, Male
    Units:
        Female
    		 13 13
        Male
    		 17 17
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 30 30
        Unknown or Not Reported
    		 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 30 30
    Low-Density Lipoprotein Cholesterol (LDL-C)
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 473.5 ( 135.2 ) -
    Apolipoprotein B (ApoB)
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 275.3 ( 69.1 ) -
    Lipoprotein(a) (Lp[a])
    Units: nmol/L
        arithmetic mean (standard deviation)
    		 201.3 ( 177.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    Evolocumab
    Reporting group description
    		 Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).

    Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    Includes both serious and non-serious TEAEs. Adverse event (AE): any untoward medical occurrence in a participant. Serious AE (SAE): an AE that meets 1 on the following serious criteria: fatal; life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. TEAE: any AE starting on or after the first dose of study drug and up to and including 30 days after the last dose of study drug or the end of study date, whichever is earlier.
    End point type
    Primary
    End point timeframe
    12 weeks
    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: Descriptive statistics are presented, per protocol.
    End point values
    		 Evolocumab
    Number of subjects analysed
    30
    Units: participants
    10
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)

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    End point title
    		 Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)
    End point description
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 Evolocumab
    Number of subjects analysed
    29
    Units: percentage
        arithmetic mean (standard deviation)
    -6.4 ( 22.7 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)

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    End point title
    		 Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
    End point description
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 Evolocumab
    Number of subjects analysed
    29
    Units: percentage
        arithmetic mean (standard deviation)
    -6.0 ( 19.8 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline to Week 12 in Lipoprotein(a) (Lp[a])

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    End point title
    		 Percent Change From Baseline to Week 12 in Lipoprotein(a) (Lp[a])
    End point description
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 Evolocumab
    Number of subjects analysed
    29
    Units: percentage
        arithmetic mean (standard deviation)
    -0.2 ( 26.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Fatal adverse events: from first dose date to the end of study date (week 12). Non-fatal adverse events: from the first dose of study drug up to 30 days after the last dose (at week 8) or until the end of study date (week 12), whichever was earlier.
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs) are presented. TEAE: any AE starting on or after the first dose of study drug and up to and including 30 days after the last dose of study drug or the end of study date, whichever is earlier.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Evolocumab
    Reporting group description
    		 Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).

    Serious adverse events
    		 Evolocumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 30 (6.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Evolocumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 30 (26.67%)
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Injection site swelling
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Diabetic wound
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Skin fissures
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Arthritis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Infections and infestations
    Pyoderma
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Varicella
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    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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