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    Clinical Trial Results:
    heiGHt: A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of lonapegsomatropin administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD)

    Summary
    EudraCT number
    		 2016-001145-11
    Trial protocol
    		 DE   IT   BG   PL   GR  
    Global end of trial date
    17 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Sep 2020
    First version publication date
    02 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TransCon hGH CT-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02781727
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ascendis Pharma A/S
    Sponsor organisation address
    Tuborg Boulevard 12, Hellerup, Denmark, 2900
    Public contact
    Clinical Trial Information Desk, Ascendis Pharma A/S, +45 70 22 22 44, clinhelpdesk@ascendispharma.com
    Scientific contact
    Clinical Trial Information Desk, Ascendis Pharma A/S, +45 70 22 22 44, clinhelpdesk@ascendispharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002692-PIP01-19
    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
    17 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate and compare the annualized height velocity of prepubertal children with growth failure due to GHD treated with weekly lonapegsomatropin to that of a commercially available daily hGH formulation at 52 weeks.
    Protection of trial subjects
    Institutional review board and independent ethics committee approval as well as signed informed consent from subjects was obtained prior to any trial-specific procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Armenia: 10
    Country: Number of subjects enrolled
    Georgia: 11
    Country: Number of subjects enrolled
    Belarus: 5
    Country: Number of subjects enrolled
    Ukraine: 12
    Country: Number of subjects enrolled
    Turkey: 4
    Country: Number of subjects enrolled
    Romania: 3
    Country: Number of subjects enrolled
    Russian Federation: 50
    Country: Number of subjects enrolled
    New Zealand: 6
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    United States: 42
    Worldwide total number of subjects
    162
    EEA total number of subjects
    20
    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)
    133
    Adolescents (12-17 years)
    29
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 54 sites in 14 countries enrolled subjects (Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and United States). Subject screening was initiated in November 2016 and the final subject visit was in January 2019.

    Pre-assignment
    Screening details
    		 Screening lasted up to 6 weeks, plus a recommended period of up to 2 weeks between randomization and Visit 1.

    Pre-assignment period milestones
    Number of subjects started
    		 162
    Number of subjects completed
    		 161

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk
    Arm description
    		 Once weekly subcutaneous injection of lonapegsomatropin equivalent to 0.24 mg hGH/kg/wk for 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lonapegsomatropn
    Investigational medicinal product code
    ACP-011
    Other name
    TransCon hGH
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lonapegsomatropin was provided as a lyophilized powder, in single-use glass vials, reconstituted with 1 mL sterile water for injection, and administered via syringe and needle as a once-weekly subcutaneous injection of 0.24 mg hGH/kg/week.

    Arm title
    		 Genotropin, 0.24 mg hGH/kg/wk
    Arm description
    		 Once daily subcutaneous injection of human Growth Hormone (Genotropin) equivalent to 0.24 mg hGH/kg/week for 52 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Genotropin
    Investigational medicinal product code
    Other name
    Human growth hormone, somatropin
    Pharmaceutical forms
    Powder and solvent for solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Genotropin was administered as a daily subcutaneous injection in a standard dose of 0.24 mg hGH/kg/week. The total weekly dose was equally split into 7 daily doses of 0.034 mg hGH/kg/day. A commercially-approved injection device was used for administration of the trial drug.

    Number of subjects in period 1 [1]
    		Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Started
    105
    56
    Completed
    104
    55
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 162 subjects were randomized to the study drug in a 2:1 manner. Among randomized subjects, 161 were dosed with a study drug and 1 subject withdrew consent and did not receive a study drug. 105 subjects received lonapegsomatropin and 56 subjects received Genotropin. Nearly all randomized and dosed subjects completed the trial (159/161).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lonapegsomatropin, 0.24 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of lonapegsomatropin equivalent to 0.24 mg hGH/kg/wk for 52 weeks.

    Reporting group title
    Genotropin, 0.24 mg hGH/kg/wk
    Reporting group description
    		 Once daily subcutaneous injection of human Growth Hormone (Genotropin) equivalent to 0.24 mg hGH/kg/week for 52 weeks.

    Reporting group values
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk Total
    Number of subjects
    		 105 56 161
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.5 ( 2.7 ) 8.5 ( 2.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 10 29
        Male
    		 86 46 132
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 112.93 ( 14.09 ) 112.15 ( 15.29 ) -
    Height SDS
    Units: Standard deviation score (SDS)
        arithmetic mean (standard deviation)
    		 -2.89 ( 0.85 ) -3.00 ( 0.90 ) -
    BMI
    Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 16.06 ( 1.78 ) 16.46 ( 2.17 ) -
    BMI SDS
    Units: Standard deviation score (SDS)
        arithmetic mean (standard deviation)
    		 -0.32 ( 0.95 ) -0.14 ( 1.07 ) -
    IGF-1 SDS
    Units: Standard deviation score (SDS)
        arithmetic mean (standard deviation)
    		 -2.08 ( 0.88 ) -1.96 ( 0.98 ) -

    End points

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    End points reporting groups
    Reporting group title
    Lonapegsomatropin, 0.24 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of lonapegsomatropin equivalent to 0.24 mg hGH/kg/wk for 52 weeks.

    Reporting group title
    Genotropin, 0.24 mg hGH/kg/wk
    Reporting group description
    		 Once daily subcutaneous injection of human Growth Hormone (Genotropin) equivalent to 0.24 mg hGH/kg/week for 52 weeks.

    Primary: AHV at 52 weeks for weekly lonapegsomatropin and daily hGH treatment groups

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    End point title
    		 AHV at 52 weeks for weekly lonapegsomatropin and daily hGH treatment groups
    End point description
    Annualized height velocity (AHV) in cm/year at week 52.
    End point type
    Primary
    End point timeframe
    52 weeks
    End point values
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects analysed
    105
    56
    Units: cm/year
        least squares mean (standard error)
    11.17 ( 0.23 )
    10.31 ( 0.30 )
    Statistical analysis title
    		 Analysis of Covariance (ANCOVA) Model
    Statistical analysis description
    ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable, treatment and gender as factors, baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.
    Comparison groups
    Lonapegsomatropin, 0.24 mg hGH/kg/wk v Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.0088 [2]
    Method
    		 ANCOVA with multiple imputation
    Confidence interval
    Notes
    [1] - Non-inferiority margin of 2 cm/year
    [2] - two-sided

    Secondary: AHV for the lonapegsomatropin and the daily hGH treatment groups over 52 weeks

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    End point title
    		 AHV for the lonapegsomatropin and the daily hGH treatment groups over 52 weeks
    End point description
    Annualized height velocity (AHV) in cm/year by visit over 52 weeks.
    End point type
    Secondary
    End point timeframe
    At Week 5, Week 13, Week 26, Week 39, and Week 52.
    End point values
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects analysed
    105
    56
    Units: cm/year
    least squares mean (standard error)
        Week 5
    13.54 ( 1.07 )
    12.83 ( 1.37 )
        Week 13
    13.28 ( 0.49 )
    12.22 ( 0.63 )
        Week 26
    12.65 ( 0.32 )
    11.21 ( 0.42 )
        Week 39
    11.89 ( 0.26 )
    10.90 ( 0.33 )
        Week 52
    11.17 ( 0.23 )
    10.31 ( 0.30 )
    Statistical analysis title
    		 ANCOVA model
    Statistical analysis description
    ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable, treatment and gender as factors, baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.
    Comparison groups
    Lonapegsomatropin, 0.24 mg hGH/kg/wk v Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0088 [3]
    Method
    		 ANCOVA with multiple imputation
    Confidence interval
    Notes
    [3] - Week 5, P = 0.6402 Week 13, P = 0.1286 Week 26, P = 0.0017 Week 39, P = 0.0061 Week 52, P =0.0088 (two-sided)

    Secondary: Change from baseline in Height SDS over 52 weeks for the lonapegsomatropin and the daily hGH treatment groups

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    End point title
    		 Change from baseline in Height SDS over 52 weeks for the lonapegsomatropin and the daily hGH treatment groups
    End point description
    Change from baseline in height (HT) standard deviation score by visit over 52 weeks.
    End point type
    Secondary
    End point timeframe
    At Week 5, Week 13, Week 26, Week 39, and Week 52.
    End point values
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects analysed
    105
    56
    Units: Standard deviation score (SDS)
    least squares mean (standard error)
        Week 5
    0.13 ( 0.02 )
    0.12 ( 0.02 )
        Week 13
    0.38 ( 0.02 )
    0.33 ( 0.03 )
        Week 26
    0.68 ( 0.03 )
    0.58 ( 0.04 )
        Week 39
    0.92 ( 0.03 )
    0.80 ( 0.04 )
        Week 52
    1.10 ( 0.04 )
    0.96 ( 0.05 )
    Statistical analysis title
    		 ANCOVA model
    Statistical analysis description
    ANCOVA model included baseline age, peak GH levels (log transformed) at stimulation test and baseline height SDS as covariates, as well as treatment and gender as factors.
    Comparison groups
    Genotropin, 0.24 mg hGH/kg/wk v Lonapegsomatropin, 0.24 mg hGH/kg/wk
    Number of subjects included in analysis
    161
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.0149 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - Week 5, P = 0.7795 Week 13, P = 0.1078 Week 26, P = 0.0085 Week 39, P = 0.0130 Week 52, P = 0.0149 (two-sided)

    Secondary: Average IGF-1 SDS by visit

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    End point title
    		 Average IGF-1 SDS by visit
    End point description
    Average IGF-1 standard deviation score by visit over 52 weeks.
    End point type
    Secondary
    End point timeframe
    At Week 13, Week 26, Week 39, and Week 52.
    End point values
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects analysed
    105
    56
    Units: Standard deviation score (SDS)
    least squares mean (standard error)
        Week 13
    0.31 ( 0.09 )
    -0.60 ( 0.11 )
        Week 26
    0.46 ( 0.08 )
    -0.51 ( 0.10 )
        Week 39
    0.59 ( 0.09 )
    -0.30 ( 0.11 )
        Week 52
    0.72 ( 0.09 )
    -0.02 ( 0.12 )
    Statistical analysis title
    		 ANCOVA model
    Statistical analysis description
    ANCOVA model included baseline age, peak GH levels (log transformed) at stimulation test, baseline IGF-1 SDS as covariates, treatment and gender as factors. Modeled values begin at Week 13 corresponding with achievement of IGF-1 steady state. Average IGF-1 SDS values by visit for the Lonapegsomatropin group were derived from a population PD model; the average IGF-1 SDS values for the Genotropin group are represented by observed values.
    Comparison groups
    Lonapegsomatropin, 0.24 mg hGH/kg/wk v Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - P <0.0001 at Weeks 13, 26, 39, and 52 (two-sided)

    Secondary: IGFBP-3 SDS by visit

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    End point title
    		 IGFBP-3 SDS by visit
    End point description
    IGFBP-3 standard deviation score by visit over 52 weeks.
    End point type
    Secondary
    End point timeframe
    At Week 5, Week, 13, Week 26, Week 39, and Week 52.
    End point values
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects analysed
    105
    56
    Units: Standard deviation score (SDS)
    least squares mean (standard error)
        Week 5
    -0.62 ( 0.07 )
    -0.36 ( 0.09 )
        Week 13
    0.34 ( 0.08 )
    -0.38 ( 0.11 )
        Week 26
    0.28 ( 0.08 )
    -0.30 ( 0.10 )
        Week 39
    0.42 ( 0.07 )
    -0.18 ( 0.10 )
        Week 52
    -0.22 ( 0.07 )
    0.01 ( 0.10 )
    Statistical analysis title
    		 Mixed Model for Repeated Measurement (MMRM) model
    Statistical analysis description
    MMRM model includes baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline IGFBP-3 SDS as covariates, treatment, visit, treatment by visit interaction, and gender as fixed factors, and subject as random effect.
    Comparison groups
    Lonapegsomatropin, 0.24 mg hGH/kg/wk v Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0454 [6]
    Method
    		 MMRM
    Confidence interval
    Notes
    [6] - Week 5, P = 0.0134 Week 13, P < 0.0001 Week 26, P < 0.0001 Week 39, P < 0.0001 Week 52, P = 0.0454 (two-sided)

    Secondary: Incidence of treatment emergent anti-hGH binding antibody formation

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    End point title
    		 Incidence of treatment emergent anti-hGH binding antibody formation
    End point description
    Incidence of treatment emergent anti-hGH binding antibody formation during the 52 week study. All samples were negative for anti-hGH neutralizing antibodies.
    End point type
    Secondary
    End point timeframe
    Start of study treatment through Week 52.
    End point values
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Number of subjects analysed
    105
    56
    Units: Subjects
    6
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52).
    Adverse event reporting additional description
    An adverse event is defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Lonapegsomatropin, 0.24 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of lonapegsomatropin equivalent to 0.24 mg hGH/kg/wk for 52 weeks.

    Reporting group title
    Genotropin, 0.24 mg hGH/kg/wk
    Reporting group description
    		 Once daily subcutaneous injection of human Growth Hormone (Genotropin) equivalent to 0.24 mg hGH/kg/week for 52 weeks.

    Serious adverse events
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 56 (1.79%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lonapegsomatropin, 0.24 mg hGH/kg/wk Genotropin, 0.24 mg hGH/kg/wk
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 105 (77.14%)
    39 / 56 (69.64%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 105 (12.38%)
    7 / 56 (12.50%)
         occurrences all number
    13
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    16 / 105 (15.24%)
    5 / 56 (8.93%)
         occurrences all number
    16
    5
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    9 / 105 (8.57%)
    3 / 56 (5.36%)
         occurrences all number
    9
    3
    Diarrhea
         subjects affected / exposed
    6 / 105 (5.71%)
    3 / 56 (5.36%)
         occurrences all number
    6
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 105 (9.52%)
    4 / 56 (7.14%)
         occurrences all number
    10
    4
    Endocrine disorders
    Secondary hypothyroidism
         subjects affected / exposed
    7 / 105 (6.67%)
    3 / 56 (5.36%)
         occurrences all number
    7
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 105 (11.43%)
    8 / 56 (14.29%)
         occurrences all number
    12
    8
    Pharyngitis
         subjects affected / exposed
    10 / 105 (9.52%)
    10 / 56 (17.86%)
         occurrences all number
    10
    10
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 105 (5.71%)
    5 / 56 (8.93%)
         occurrences all number
    6
    5
    Respiratory tract infection
         subjects affected / exposed
    7 / 105 (6.67%)
    3 / 56 (5.36%)
         occurrences all number
    7
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2017
    The amendment to the original protocol was issued to incorporate feedback from international regulatory agencies and to add pertinent clarifications and administrative edits. The amendment maintained the original intent of the protocol and aligned where possible, with current standard medical practice across various regions globally.

    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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