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    Clinical Trial Results:
    A Phase II multicenter, placebo-controlled, proof-of-concept study evaluating the safety, and efficacy of intratympanic STR001 thermogel to preserve residual hearing in adults undergoing cochlear implant surgery

    Summary
    EudraCT number
    		 2015-002672-25
    Trial protocol
    		 DE   ES   IT  
    Global end of trial date
    15 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Sep 2019
    First version publication date
    25 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    STR001-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Strekin AG
    Sponsor organisation address
    Hochbergerstrasse 60C, Basel, Switzerland, 4057
    Public contact
    CEO, Strekin AG, 0041 797888252, Alexander.bausch@strekin.com
    Scientific contact
    CEO, Strekin AG, 0041 797888252, Alexander.bausch@strekin.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
    22 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of STR001 thermogel in patients receiving cochlear implants To assess the efficacy of STR001 thermogel in preserving hearing 6 weeks after cochlear implant surgery as determined by average Pure Tone Audiometry (aPTA) values
    Protection of trial subjects
    Study reviewed by idependent ethics committees in all countries according to regulations. Subjects were treated within the usual setting and procedure of receiving a cochela implant surgery. In order to keep the potential adverse events of a local intratympanic injection lowest possible, the patient was put in a lying position and the study drug thermogel was put on body temperature before administration.
    Background therapy
    		 All patients eligible for the study were candidates to receive a cochlea implant surgery.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jan 2015
    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
    Spain: 26
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Germany: 66
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    81
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 25-Jan-2015 to 06-Oct-2017 in 4 countries: Germany, France, Italy and Spain

    Pre-assignment
    Screening details
    		 Patients were eligible for the study, if they had a moderate to severe hearing loss and were candidates to receive a cochlea implant surgery. No other specific screening details were required in the study.

    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, Monitor, Carer, Assessor
    Blinding implementation details
    Since active and placebo suspension did not have the same appearance the syringe was prepared by an unblinded study site personnel and handed over with a cover (foil) to the investigator for study drug application.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active Treatment
    Arm description
    		 Receiving STR001 thermogel drug substance as an intratympanic injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    STR001 Thermogel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection/infusion
    Routes of administration
    Auricular use
    Dosage and administration details
    STR001 1.2% Thermogel for application of 1ml as an intratympanal injection

    Arm title
    		 Placebo
    Arm description
    		 Receiving STR001 Placebo Thermogel for intratympanic injection
    Arm type
    		 Placebo

    Investigational medicinal product name
    STR001 Placebo Thermogel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Auricular use
    Dosage and administration details
    STR001 Placebo Thermogel for 1mL intratymanal injection of study drug

    Number of subjects in period 1
    		Active Treatment Placebo
    Started
    55
    55
    Completed
    55
    55

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active Treatment
    Reporting group description
    		 Receiving STR001 thermogel drug substance as an intratympanic injection

    Reporting group title
    Placebo
    Reporting group description
    		 Receiving STR001 Placebo Thermogel for intratympanic injection

    Reporting group values
    		 Active Treatment Placebo Total
    Number of subjects
    		 55 55 110
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 43 38 81
        From 65-84 years
    		 12 17 29
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 33 27 60
        Male
    		 22 28 50
    Subject analysis sets

    Subject analysis set title
    ITT Analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all randomised patients. ITT patients will be analysed in the treatment group they were randomized to, regardless of the treatment they may have received.

    Subject analysis sets values
    		 ITT Analysis
    Number of subjects
    110
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    81
        From 65-84 years
    29
        85 years and over
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    60
        Male
    50

    End points

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    End points reporting groups
    Reporting group title
    Active Treatment
    Reporting group description
    		 Receiving STR001 thermogel drug substance as an intratympanic injection

    Reporting group title
    Placebo
    Reporting group description
    		 Receiving STR001 Placebo Thermogel for intratympanic injection

    Subject analysis set title
    ITT Analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all randomised patients. ITT patients will be analysed in the treatment group they were randomized to, regardless of the treatment they may have received.

    Primary: Pure Tone Audiometry Threshold of the implanted ear as the average (aPTA) of the following frequencies: 125, 250, 500 and 750 Hz at Week 6

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    End point title
    		 Pure Tone Audiometry Threshold of the implanted ear as the average (aPTA) of the following frequencies: 125, 250, 500 and 750 Hz at Week 6
    End point description
    To assess the efficacy of STR001 thermogel in preserving hearing 6 weeks after cochlear implant surgery as determined by average Pure Tone Audiometry (aPTA) values
    End point type
    Primary
    End point timeframe
    Baseline - week 6
    End point values
    		 Active Treatment Placebo ITT Analysis
    Number of subjects analysed
    53
    54
    107
    Units: PTA Threshold
        arithmetic mean (standard deviation)
    25 ( 16 )
    27 ( 16 )
    26 ( 16 )
    Attachments
    		 Untitled (Filename: Efficacy chart for result posting.JPG)
    Statistical analysis title
    		 aPTA (average pure tone audiometry threshold)
    Statistical analysis description
    Descriptive statistics and change from baseline to Week 6, were performed on PTA values for original imputation method (no significant treatment effect favouring STR001 was detected, no conservative analysis performed)
    Comparison groups
    Placebo v Active Treatment
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 5
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 10.5
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Dispersion value
    20
    Notes
    [1] - The average postoperative hearing loss was in the same range for both treatment arms. For the STR001 arm the average hearing loss was 25±16 dB while for the placebo arm the average hearing loss was 27±16 dB. The nominal difference between the two groups was not statistically significant. The primary study objective was not met.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline - week 6
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Active Treatment STR001
    Reporting group description
    		 -

    Reporting group title
    Placebo Treatment Group
    Reporting group description
    		 -

    Serious adverse events
    		 Active Treatment STR001 Placebo Treatment Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 55 (5.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    admission to other hospital due to Suspected Acute Coronary Syndrome
    Additional description: Acute Coronary Syndrome
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    worsening hearing
    Additional description: hypoacusis
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Increased inner ear pressure
    Additional description: Inner ear disorder
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ear complete deafness
    Additional description: deafness unilateral
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Severe Bladder voiiding disturbance
    Additional description: Dysuria
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 55 (5.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active Treatment STR001 Placebo Treatment Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 53 (41.51%)
    23 / 55 (41.82%)
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    2 / 53 (3.77%)
    4 / 55 (7.27%)
         occurrences all number
    2
    4
    Dizziness
         subjects affected / exposed
    5 / 53 (9.43%)
    5 / 55 (9.09%)
         occurrences all number
    5
    6
    Ear and labyrinth disorders
    ear pain
         subjects affected / exposed
    4 / 53 (7.55%)
    5 / 55 (9.09%)
         occurrences all number
    5
    11
    Tinnitus
         subjects affected / exposed
    6 / 53 (11.32%)
    2 / 55 (3.64%)
         occurrences all number
    7
    2
    Vertigo labyrinthine
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2015
    Amendment 1 - non substantial To clarify inconsistencies in Day numbering throughout the protocol.
    19 Nov 2015
    Amendment 2 - non substantial (France only) To clarify vaccination eligibility -vaccination against Streptococcus pneumoniae must be allowed.
    24 Nov 2015
    Amendment 3 - non substantial (Germany only) to clarify sample size justification
    04 Dec 2015
    Amendment 4 - non substantial (Germany only) to remove text in the protocol not applicable for study population.
    26 Jan 2016
    Amendment 5 - non substantial To harmonize the inclusion criterion number 2 with the primary objective.
    26 Jan 2016
    Amendment 6 - non-substantial (France only) To clarify vaccination eligibility following the request of the French Health Authorities.
    09 Feb 2016
    Amendment 7 - non-substantial (France only) To address a request from the French Health Authorities in order to comply with eligibility criteria of patients for Cochlear Implant surgery in France.
    25 Feb 2016
    Amendment 8 - non-substantial the average differences of BCTA and PTA are removed from the protocol as an inclusion criterion as well as in the definition of the efficacy analysis population.
    10 Jun 2016
    Amendment 9 - non-substantial include more electrodes/increase age for inclusion criterion/add clarification of use of steroids/adapt number of countries and sites

    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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