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    Clinical Trial Results:
    A Phase IIA, Open-Label, Single-Arm, Two Stage, Multi-Centre Study to Investigate the Pharmacodynamics, Pharmackinetics, Safety and Tolerability of Repeated Subcutaneous Administration of BIM23B065 in Subjects with Acromegaly

    Summary
    EudraCT number
    		 2015-003868-37
    Trial protocol
    		 HU   BE   BG  
    Global end of trial date
    26 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Aug 2018
    First version publication date
    03 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D-FR-10380-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03045302
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma SAS
    Sponsor organisation address
    65, quai Georges Gorse, Boulogne-Billancourt, France, 92100
    Public contact
    Medical Director, Ipsen Pharma SAS, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Pharma SAS, clinical.trials@ipsen.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
    26 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the pharmacodynamics (PD) of repeated administration of BIM23B065 in reducing growth hormone (GH) in subjects with acromegaly.
    Protection of trial subjects
    The study was conducted under the provision of the Declaration of Helsinki, in accordance with the International Council for Harmonisation Consolidated Guideline on Good Clinical Practice and in compliance with Independent Ethic Committees/Independent Review Boards and informed consent regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jan 2017
    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
    Hungary: 2
    Country: Number of subjects enrolled
    Ukraine: 2
    Worldwide total number of subjects
    4
    EEA total number of subjects
    2
    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)
    3
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects with acromegaly were recruited from 26 January 2017 in 4 study centres in 4 countries. Stage 1 of the study consisted of a twice daily (BID) regimen of BIM23B065, and a Stage 2 with a three times daily regimen of BIM23B065 was planned but not conducted due to early termination of the study on 26 May 2017.

    Pre-assignment
    Screening details
    		 7 subjects were screened and 3 failed screening (1 subject did not meet elgibility criteria and 2 subjects did not complete screening procedures due to the early study termination).

    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
    		 BIM23B065 BID Stage 1
    Arm description
    		 Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase. Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2), then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6). Treatment phase (Days 7 to 14): Following titration, a stable target dose of BIM23B065 1.0 mg BID was planned to be administered from Day 7 to Day 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BIM23B065
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received subcutaneous injections BID in the abdominal region administered by a healthcare professional. During the treatment period the possible doses of BIM23B065 (1.0 mg/millilitre [mL]) were: 0.4 mg, 0.6 mg, 0.8 mg up to a target dose of 1.0 mg BID administered as volumes of 0.4 mL, 0.6 mL, 0.8 mL or 1.0 mL respectively.

    Number of subjects in period 1
    		BIM23B065 BID Stage 1
    Started
    4
    Completed
    3
    Not completed
    1
         Pre-treatment adverse event
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BIM23B065 BID Stage 1
    Reporting group description
    		 Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase. Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2), then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6). Treatment phase (Days 7 to 14): Following titration, a stable target dose of BIM23B065 1.0 mg BID was planned to be administered from Day 7 to Day 14.

    Reporting group values
    		 BIM23B065 BID Stage 1 Total
    Number of subjects
    		 4
    Age categorical
    Units: Subjects
    Age continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 53.0 ( 15.12 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Black or African American
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        White
    		 4 4
        Unknown or Not Reported
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 4 4
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    BIM23B065 BID Stage 1
    Reporting group description
    		 Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase. Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2), then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6). Treatment phase (Days 7 to 14): Following titration, a stable target dose of BIM23B065 1.0 mg BID was planned to be administered from Day 7 to Day 14.

    Primary: The number of subjects who were GH Responders at Day 14 of the Treatment Period

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    End point title
    		 The number of subjects who were GH Responders at Day 14 of the Treatment Period [1]
    End point description
    A GH responder was defined as a subject with mean serum GH concentration ≤2.5 micrograms per litre (mcg/L) or >50% reduction from mean baseline GH concentration after a 6-day titration and an 8-day treatment period with BIM23B065. The mean serum concentration of GH was measured over 6 hours at baseline (Day -1) and on Day 14. The number of subjects who were GH responders at Day 14 of the treatment period is presented. The Efficacy Evaluable population consisted of all subjects with at least 1 BIM23B065 administration with available PD data and no protocol deviations with relevant impact on PD data, who had an evaluable primary efficacy endpoint (mean concentration of GH over 6 hours) at baseline and at Day 14.
    End point type
    Primary
    End point timeframe
    From baseline (Day -1) to Day 14.
    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: Data is reported for Stage 1 of the study which was a single reporting group stage and therefore comparative statistical analyses between groups is not applicable.
    End point values
    		 BIM23B065 BID Stage 1
    Number of subjects analysed
    3
    Units: Subjects
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were collected from Day 1 of the treatment period up to the end of the study (up to 4 months).
    Adverse event reporting additional description
    The Safety population consisted of all subjects with at least 1 BIM23B065 administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    BIM23B065 BID Stage 1
    Reporting group description
    		 Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase. Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 mg BID (Days 1 and 2), then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6). Treatment phase (Days 7 to 14): Following titration, a stable target dose of BIM23B065 1.0 mg BID was planned to be administered from Day 7 to Day 14.

    Serious adverse events
    		 BIM23B065 BID Stage 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 BIM23B065 BID Stage 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Sep 2016
    - An additional exclusion criterion was added, to exclude subjects with unsubstituted/untreated hypoadrenalism. - Serum cortisol was added as a safety endocrine parameter. - The total blood volume was amended in the Blood Sampling Summary. - The Global Patient Safety contact details were amended.

    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.
    The sponsor stopped the study early as the preliminary results in 3 subjects dosed with BIM23B065 showed an inadequate PD profile and efficacy. The enrolled subjects only received BID treatment. Only the primary endpoint results are 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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