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    Clinical Trial Results:
    DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS.

    Summary
    EudraCT number
    		 2017-002710-31
    Trial protocol
    		 DE   CZ   HU   RO  
    Global end of trial date
    29 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Oct 2019
    First version publication date
    17 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SCGAM-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03686969
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 17515
    Sponsors
    Sponsor organisation name
    Octapharma Pharmazeutika Produktionsges.m.b.H.
    Sponsor organisation address
    Oberlaaer Strasse 235, Vienna, Austria, 1100
    Public contact
    Global Clinical Project Manager, Octapharma Pharmazeutika Produktionsges.m.b.H. , 43 1610321202, clinical.department@octapharma.com
    Scientific contact
    Global Clinical Project Manager, Octapharma Pharmazeutika Produktionsges.m.b.H. , 43 1610321202, clinical.department@octapharma.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
    16 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the efficacy of subcutaneous immunoglobulin octanorm in the maintenance treatment of DM patients who have previously responded to IGIV therapy.
    Protection of trial subjects
    This trial was conducted in accordance to the principles of ICH- GCP, ensuring that the rights, safety and well-being of patients are protected and in consistency with the Declaration of Helsinki. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and risk factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as occurrence of AEs, local injection site reactions, safety labs, vital signs and physical examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2018
    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
    Russian Federation: 1
    Worldwide total number of subjects
    1
    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)
    0
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with documented diagnosis of dermatomyositis who have previously responded to IGIV treatment were to be enrolled in the study on the basis of the in- and exclusion criteria defined in the study protocol.

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

    Arms
    Arm title
    		 octanorm or placebo
    Arm description
    		 Subjects were to be randomly assigned to either 0.5 g/kg/week octanorm or to placebo. A dose of 0.5 g/kg/week had to be administered subcutaneously every week (±2 days). A minimum interval of 4 days must have been kept in between two consecutive subcutaneous infusion cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    octanorm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The only patient treated in the study was assigned to octanorm. Octanorm had to be administered subcutaneously every week (±2 days) using a syringe driver for precise infusion rates. The total dose/volume of a weekly infusion was calculated on the basis of the body weight (0.5 g/kg). The weekly infusion was performed in two separate sessions (= 1 infusion cycle for a given weekly administration). An infusion cycle comprises both sessions to be administered on 1 or 2 days, either on the same day or on two consecutive days or with maximum one day in between two sessions.

    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
    A dose of 0.5 g/kg/week had to be administered subcutaneously every week (±2 days). A minimum interval of 4 days must have been kept in between two consecutive subcutaneous infusion cycles.

    Number of subjects in period 1
    		octanorm or placebo
    Started
    1
    Completed
    0
    Not completed
    1
         Premature termination of the study
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 Only one patient was enrolled. The study treatment could not be completed for the one patient enrolled because of premature study termination.

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    octanorm or placebo
    Reporting group description
    		 Subjects were to be randomly assigned to either 0.5 g/kg/week octanorm or to placebo. A dose of 0.5 g/kg/week had to be administered subcutaneously every week (±2 days). A minimum interval of 4 days must have been kept in between two consecutive subcutaneous infusion cycles.

    Primary: Clinically important deterioration

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    End point title
    		 Clinically important deterioration [1]
    End point description
    Primary endpoint is defined as the proportion of patients with clinically important deterioration during the treatment period up to Week 32. A patient with clinically important deterioration is defined as a patient with 1) MMT 8 worsening ≥ 6 points (scale of 150) OR CDASI worsening ≥ 5 points, AND 2) a Physician’s Global Disease Activity VAS worsening ≥ 2 cm.
    End point type
    Primary
    End point timeframe
    week 32
    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: In view of the limited data available (only from one patient), no efficacy and safety analyses were performed.
    End point values
    		 octanorm or placebo
    Number of subjects analysed
    0 [2]
    Units: proportion
        number (not applicable)
    Notes
    [2] - Only 1 patient was enrolled. Because of premature termination of the study no analysis was possible.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the whole study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    octanorm or placebo
    Reporting group description
    		 Subjects were to be randomly assigned to either 0.5 g/kg/week octanorm or to placebo. A dose of 0.5 g/kg/week had to be administered subcutaneously every week (±2 days). A minimum interval of 4 days must have been kept in between two consecutive subcutaneous infusion cycles.

    Serious adverse events
    		 octanorm or placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (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
    		 octanorm or placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Infusion site haematoma
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Dermatomyositis, Myalgia worsening
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dermatomyositis, Gottron´s sign worsening
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Infections and infestations
    Aldolase increased
         subjects affected / exposed
    1 / 1 (100.00%)
         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
    19 Apr 2018
    Protocol version 06 - Contraception Language updated, - pregnancy testing frequency - Dose adjustment acc. body weight measurements - study prolongation by 2 months. - Site infusions possible until 7th cycle and afterwards if deemed medically relevant by the investigator.
    16 Jul 2018
    Protocol Version 07 - number of syringe drivers adapted - clarification of concomitant medication - exclusion criteron juvenile dermatomyositis has been added - SAE reporting details updated

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    29 Nov 2018
    The study was designed to include patients from the GAM10-08 study, a prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (“ProDERM study”) as roll-over patients and new patients meeting eligibility criteria. The first site was initiated on 11-Jul-2018 and until November 2018 only one patient had been randomized. Between July and November 2018 more than 10 potentially eligible roll over patients refused to participate in the study SCGAM-02. Based on the analysis of the reasons of the patients’ refusals it was decided to terminate the study because of the higher than expected study complexity and slow enrolment.
    -

    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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