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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism

    Summary
    EudraCT number
    		 2020-003380-26
    Trial protocol
    		 DK   NO   FR   DE   HU   IT  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2023
    First version publication date
    27 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TCP-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04701203
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ascendis Pharma Bone Diseases A/S
    Sponsor organisation address
    Tuborg Boulevard 12, Hellerup, Denmark, DK 2900
    Public contact
    Clinical Trial Information Desk , Ascendis Pharma Bone Diseases A/S, 45 70222244, clinhelpdesk@ascendispharma.com
    Scientific contact
    Clinical Trial Information Desk , Ascendis Pharma Bone Diseases A/S, 45 70222244, clinhelpdesk@ascendispharma.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
    Interim
    Date of interim/final analysis
    15 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jan 2022
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To assess the treatment effect of daily TransCon PTH on serum calcium levels, and therapeutic doses of active vitamin D (i.e., calcitriol or alfacalcidol) and calcium at 26 weeks of treatment.
    Protection of trial subjects
    Written informed consent was obtained from all subjects prior to enrollment into the trial, as dictated by the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Dec 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 30
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Italy: 11
    Worldwide total number of subjects
    82
    EEA total number of subjects
    31
    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)
    72
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 82 subjects were enrolled and dosed. Enrollment of subjects occurred in seven countries: Canada, Denmark, Germany, Italy, Hungary, Norway, and the United States.

    Pre-assignment
    Screening details
    		 A total of 106 subjects were screened and 84 of these met eligibility criteria and were enrolled into the study. Two subjects randomized to TransCon PTH were not treated. A total of 82 subjects were therefore included in the ITT and the Safety analysis populations.

    Pre-assignment period milestones
    Number of subjects started
    		 84 [1]
    Number of subjects completed
    		 82

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 84 subjects met eligibility criteria and were enrolled into the study. However, 2 subjects randomized to TransCon PTH were not treated.
    Period 1
    Period 1 title
    26 Week Blinded Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TransCon PTH
    Arm description
    		 Once daily subcutaneous administration of TransCon PTH at a starting dose of 18 mcg/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    TransCon PTH
    Investigational medicinal product code
    ACP-014
    Other name
    Palopegteriparatide
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TransCon PTH drug product was supplied as a clear solution containing palopegteriparatide with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. All subjects were initially prescribed TransCon PTH 18 μg PTH(1-34)/d and were individually and progressively titrated to an optimal dose (allowable range 6–60 μg/d) in increments of 3 μg/d. Titration of study drug and conventional therapy was performed according to a protocol-specified algorithm guided by serum calcium values.

    Arm title
    		 Placebo
    Arm description
    		 Once daily subcutaneous administration of placebo for TransCon PTH to mimick the dose of investigational product
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for TransCon PTH drug product was supplied as a clear solution containing placebo liquid to match the investigational product in a pre-filled pen intended for subcutaneous injection.

    Number of subjects in period 1
    		TransCon PTH Placebo
    Started
    61
    21
    Completed
    60
    19
    Not completed
    1
    2
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TransCon PTH
    Reporting group description
    		 Once daily subcutaneous administration of TransCon PTH at a starting dose of 18 mcg/day

    Reporting group title
    Placebo
    Reporting group description
    		 Once daily subcutaneous administration of placebo for TransCon PTH to mimick the dose of investigational product

    Reporting group values
    		 TransCon PTH Placebo Total
    Number of subjects
    		 61 21 82
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.0 ( 13.13 ) 47.3 ( 11.43 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 18 64
        Male
    		 15 3 18
    Race
    Units: Subjects
        Asian
    		 3 2 5
        White
    		 57 19 76
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 57 18 75
        Not Reported
    		 3 1 4
        Unknown
    		 1 2 3
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 168.22 ( 8.353 ) 166.67 ( 8.831 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 77.18 ( 17.335 ) 81.61 ( 15.631 ) -
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 27.27 ( 5.813 ) 29.47 ( 5.691 ) -

    End points

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    End points reporting groups
    Reporting group title
    TransCon PTH
    Reporting group description
    		 Once daily subcutaneous administration of TransCon PTH at a starting dose of 18 mcg/day

    Reporting group title
    Placebo
    Reporting group description
    		 Once daily subcutaneous administration of placebo for TransCon PTH to mimick the dose of investigational product

    Primary: Efficacy - Primary Endpoint

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    End point title
    		 Efficacy - Primary Endpoint
    End point description
    The proportion of subjects with albumin-adjusted serum calcium measured within 4 weeks prior to and on Week 26 visit within the normal range (8.3 to 10.6 mg/dL), and independence from active vitamin D within 4 weeks prior to Week 26 visit (i.e., all daily standing dose of active vitamin D equal to zero AND use of PRN ≤7 days during the 4 weeks), and independence from therapeutic doses of calcium within 4 weeks prior to Week 26 visit (i.e., average daily standing dose of elemental calcium ≤600 mg AND use of PRN doses on ≤7 days during the 4 weeks) and, no increase in prescribed study drug within 4 weeks prior to Week 26 visit.
    End point type
    Primary
    End point timeframe
    26 weeks
    End point values
    		 TransCon PTH Placebo
    Number of subjects analysed
    61
    21
    Units: Percent
        number (confidence interval 95%)
    78.7 (66.3 to 88.1)
    4.8 (0.1 to 23.8)
    Statistical analysis title
    		 Primary efficacy endpoint
    Statistical analysis description
    For the primary efficacy endpoint, the Cochran–Mantel Haenszel test stratified by etiology of hypoparathyroidism (postsurgical or other) was used to compare the proportion of participants meeting the composite primary endpoint in the TransCon PTH versus placebo groups. Participants without week 26 albumin-adjusted serum calcium or with >25% (ie, >7 days) missing diary data of active vitamin D or elemental calcium during the 4 weeks before week 26 were considered non-responders.
    Comparison groups
    TransCon PTH v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: HPES - Symptom - Physical Domain Score

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    End point title
    		 HPES - Symptom - Physical Domain Score
    End point description
    Hypoparathyroidism Patient Experience Scale (HPES) - Symptom - Physical Domain score change from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism related physical symptoms.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 TransCon PTH Placebo
    Number of subjects analysed
    59
    19
    Units: LS Mean Change from Baseline
        least squares mean (confidence interval 95%)
    -21.01 (-25.41 to -16.60)
    -4.81 (-15.22 to 5.59)
    Statistical analysis title
    		 HPES - Symptom - Physical Domain Score
    Statistical analysis description
    ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.
    Comparison groups
    TransCon PTH v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0038
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: HPES - Symptom - Cognitive Domain Score

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    End point title
    		 HPES - Symptom - Cognitive Domain Score
    End point description
    Hypoparathyroidism Patient Experience Scale (HPES) - Symptom - Cognitive Domain score change from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism related cognitive symptoms.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 TransCon PTH Placebo
    Number of subjects analysed
    59
    19
    Units: LS Mean Change from Baseline
        least squares mean (confidence interval 95%)
    -20.49 (-25.67 to -15.31)
    -6.16 (-15.92 to 3.60)
    Statistical analysis title
    		 HPES - Symptom - Cognitive Domain Score
    Statistical analysis description
    ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.
    Comparison groups
    Placebo v TransCon PTH
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0055
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: HPES - Impact - Physical Functioning Domain Score

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    End point title
    		 HPES - Impact - Physical Functioning Domain Score
    End point description
    Hypoparathyroidism Patient Experience Scale (HPES) - Impact - Physical Functioning Domain score change from baseline. A decrease in HPES score denotes an improvement in health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 TransCon PTH Placebo
    Number of subjects analysed
    59
    19
    Units: LS Mean Change from Baseline
        least squares mean (confidence interval 95%)
    -18.29 (-23.59 to -12.99)
    -1.01 (-12.40 to 10.38)
    Statistical analysis title
    		 HPES - Impact - Physical Functioning Domain Score
    Statistical analysis description
    ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.
    Comparison groups
    TransCon PTH v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0046
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: HPES - Impact - Daily Life Domain Score

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    End point title
    		 HPES - Impact - Daily Life Domain Score
    End point description
    Hypoparathyroidism Patient Experience Scale (HPES) - Impact - Daily Life Domain score change from baseline. A decrease in HPES score denotes an improvement in health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 TransCon PTH Placebo
    Number of subjects analysed
    59
    19
    Units: LS Mean Change from Baseline
        least squares mean (confidence interval 95%)
    -17.65 (-22.39 to -12.91)
    -0.36 (-12.19 to 11.46)
    Statistical analysis title
    		 HPES - Impact - Daily Life Domain Score
    Statistical analysis description
    ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.
    Comparison groups
    TransCon PTH v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0061
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: SF-36 – Physical Functioning Subscale Score

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    End point title
    		 SF-36 – Physical Functioning Subscale Score
    End point description
    36-item Short Form Survey (SF-36) – Physical Functioning Subscale Score change from baseline. An increase in SF-36 score denotes an improvement in health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 TransCon PTH Placebo
    Number of subjects analysed
    59
    19
    Units: LS Mean Change from Baseline
        least squares mean (confidence interval 95%)
    5.29 (3.47 to 7.10)
    0.12 (-4.64 to 4.89)
    Statistical analysis title
    		 SF-36 – Physical Functioning Subscale Score
    Statistical analysis description
    ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.
    Comparison groups
    TransCon PTH v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0347
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    26 Week Blinded Period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    TransCon PTH
    Reporting group description
    		 Once daily subcutaneous administration of TransCon PTH at a starting dose of 18 mcg/day

    Reporting group title
    Placebo
    Reporting group description
    		 Once daily subcutaneous administration of placebo for TransCon PTH to mimick the dose of investigational product

    Serious adverse events
    		 TransCon PTH Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 61 (8.20%)
    3 / 21 (14.29%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial disorder
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcemia
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcemia
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 21 (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
    		 TransCon PTH Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 61 (81.97%)
    20 / 21 (95.24%)
    Investigations
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    2 / 61 (3.28%)
    2 / 21 (9.52%)
         occurrences all number
    2
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 61 (4.92%)
    3 / 21 (14.29%)
         occurrences all number
    3
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 61 (21.31%)
    2 / 21 (9.52%)
         occurrences all number
    20
    2
    Paraesthesia
         subjects affected / exposed
    11 / 61 (18.03%)
    3 / 21 (14.29%)
         occurrences all number
    22
    10
    Dizziness
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 21 (0.00%)
         occurrences all number
    4
    0
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    19 / 61 (31.15%)
    0 / 21 (0.00%)
         occurrences all number
    19
    0
    Fatigue
         subjects affected / exposed
    9 / 61 (14.75%)
    5 / 21 (23.81%)
         occurrences all number
    10
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 61 (11.48%)
    2 / 21 (9.52%)
         occurrences all number
    11
    3
    Diarrhoea
         subjects affected / exposed
    6 / 61 (9.84%)
    1 / 21 (4.76%)
         occurrences all number
    6
    1
    Constipation
         subjects affected / exposed
    4 / 61 (6.56%)
    1 / 21 (4.76%)
         occurrences all number
    5
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 21 (0.00%)
         occurrences all number
    4
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 61 (6.56%)
    1 / 21 (4.76%)
         occurrences all number
    4
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    7 / 61 (11.48%)
    3 / 21 (14.29%)
         occurrences all number
    9
    3
    Arthralgia
         subjects affected / exposed
    6 / 61 (9.84%)
    3 / 21 (14.29%)
         occurrences all number
    7
    3
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    5 / 61 (8.20%)
    9 / 21 (42.86%)
         occurrences all number
    7
    14
    Hypercalcaemia
         subjects affected / exposed
    5 / 61 (8.20%)
    0 / 21 (0.00%)
         occurrences all number
    8
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Mar 2021
    The protocol amendment was to address comments and recommendations from Health Authorities and provide clarification on the trial.
    10 Jun 2021
    The protocol amendment provided clarification on the trial and addressed a Health Authority comment.
    03 Aug 2021
    The protocol amendment updated the primary and secondary efficacy endpoints based on FDA recommendation.
    20 Dec 2021
    The protocol amendment updated the primary and secondary efficacy endpoints based on FDA recommendation.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36271471
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