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    Clinical Trial Results:
    Clinical evaluation of two different dosage groups of Tacrosolv over 8 days with once daily administration in a placebo controlled cross-over design to evaluate safety and efficacy in patients suffering from grass pollen-induced allergic rhinoconjunctivitis in the Vienna Challenge Chamber.

    Summary
    EudraCT number
    		 2019-002847-62
    Trial protocol
    		 AT  
    Global end of trial date
    05 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2022
    First version publication date
    22 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TCS_19_02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Marinomed Biotech AG
    Sponsor organisation address
    Hovengasse 25, Korneuburg, Austria, 2100
    Public contact
    Project Manager, Marinomed Biotech AG, +43 1250774460, svenja.sladek@marinomed.com
    Scientific contact
    CSO, Marinomed Biotech AG, +43 1250774460, eva.prieschl-grassauer@marinomed.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
    29 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial is to demonstrate the safety and efficacy of two doses of Tacrosolv (1 drop per eye per day - low dose treatment; 2 drops per eye per day - high dose treatment) in a cross-over design on day 8 of treatment.
    Protection of trial subjects
    This study was performed in compliance with the ICH E6 Guideline for Good Clinical Practice, the principles that have their origin in the Declaration of Helsinki and local laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2020
    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
    Austria: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    64
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Dates of recruitment: Beginning: 04th August 2020 End of recruitment: 13th of Jannuary 2021 Territory: Austria

    Pre-assignment
    Screening details
    		 Subjects exhibit a moderate to severe response within the first 2 hours of the challenge (4 hours in total) Total ocular symptom score (TOSS) of at least 4 (out of 12) at least one single ocular symptom scored ≥2 (“moderate”) at least twice during the first two hours

    Period 1
    Period 1 title
    Overall Study (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
    No

    Arm title
    		 Placebo 1
    Arm description
    		 32 subjects were randomised into the cross-over treatment Placebo1 and Tacrosolv high dose. One subject had a protocol deviation. 31 subjects completed the trial.
    Arm type
    		 placebo high dose

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Conjunctival use
    Dosage and administration details
    two eye drops per eye

    Arm title
    		 Tacrosolv low-dose day 8
    Arm description
    		 32 subjects were randomised into the cross-over treatment Tacrosolv low-dose and Placebo 2. One subject had a protocol deviation. 31 subjects completed the trial.
    Arm type
    		 Tacrosolv low-dose

    Investigational medicinal product name
    Tacrosolv
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Conjunctival use
    Dosage and administration details
    one eye drop per eye

    Arm title
    		 Placebo 2
    Arm description
    		 32 subjects were randomised into the cross-over treatment Placebo 2 and Tacrosolv low dose. One subject had a protocol deviation. 31 subjects completed the trial
    Arm type
    		 Placebo high dose

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Conjunctival use
    Dosage and administration details
    two eye drops per eye

    Arm title
    		 Tacrosolv high-dose day 8
    Arm description
    		 32 were randomised into the cross-over treatment Tacrsolv high dose and Placebo 1. One subject had a protocol deviation. 31 subjects completed the trial
    Arm type
    		 Tacrosolv high dose

    Investigational medicinal product name
    Tacrosolv
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, solution
    Routes of administration
    Conjunctival use
    Dosage and administration details
    two eye drops per eye

    Number of subjects in period 1
    		Placebo 1 Tacrosolv low-dose day 8 Placebo 2 Tacrosolv high-dose day 8
    Started
    32
    32
    32
    32
    Completed
    32
    32
    32
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo 1
    Reporting group description
    		 32 subjects were randomised into the cross-over treatment Placebo1 and Tacrosolv high dose. One subject had a protocol deviation. 31 subjects completed the trial.

    Reporting group title
    Tacrosolv low-dose day 8
    Reporting group description
    		 32 subjects were randomised into the cross-over treatment Tacrosolv low-dose and Placebo 2. One subject had a protocol deviation. 31 subjects completed the trial.

    Reporting group title
    Placebo 2
    Reporting group description
    		 32 subjects were randomised into the cross-over treatment Placebo 2 and Tacrosolv low dose. One subject had a protocol deviation. 31 subjects completed the trial

    Reporting group title
    Tacrosolv high-dose day 8
    Reporting group description
    		 32 were randomised into the cross-over treatment Tacrsolv high dose and Placebo 1. One subject had a protocol deviation. 31 subjects completed the trial

    Reporting group values
    		 Placebo 1 Tacrosolv low-dose day 8 Placebo 2 Tacrosolv high-dose day 8 Total
    Number of subjects
    		 32 32 32 32 64
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 32 32 32 32 64
    Gender categorical
    Units: Subjects
        Female
    		 19 19 19 19 38
        Male
    		 13 13 13 13 26

    End points

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    End points reporting groups
    Reporting group title
    Placebo 1
    Reporting group description
    		 32 subjects were randomised into the cross-over treatment Placebo1 and Tacrosolv high dose. One subject had a protocol deviation. 31 subjects completed the trial.

    Reporting group title
    Tacrosolv low-dose day 8
    Reporting group description
    		 32 subjects were randomised into the cross-over treatment Tacrosolv low-dose and Placebo 2. One subject had a protocol deviation. 31 subjects completed the trial.

    Reporting group title
    Placebo 2
    Reporting group description
    		 32 subjects were randomised into the cross-over treatment Placebo 2 and Tacrosolv low dose. One subject had a protocol deviation. 31 subjects completed the trial

    Reporting group title
    Tacrosolv high-dose day 8
    Reporting group description
    		 32 were randomised into the cross-over treatment Tacrsolv high dose and Placebo 1. One subject had a protocol deviation. 31 subjects completed the trial

    Primary: Total Ocular Symptom Score

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    End point title
    		 Total Ocular Symptom Score
    End point description
    The primary efficacy endpoint was the mean 'Total Ocular Symptom Score' (TOSS), calculated as the mean of TOSS measured every 15 minutes during the grass pollen allergen exposure challenge from time-point 0 to 4 hours on day 8. TOSS is defined as the sum of the four individual ocular symptoms:  ocular redness (red eye)  ocular itching (itchy eyes)  watery eye  gritty feeling
    End point type
    Primary
    End point timeframe
    The mean of TOSS measured every 15 minutes during the grass pollen allergen exposure challenge from time-point 0 to 4 hours on day 8.
    End point values
    		 Placebo 1 Tacrosolv low-dose day 8 Placebo 2 Tacrosolv high-dose day 8
    Number of subjects analysed
    31
    31
    31
    31
    Units: points
        arithmetic mean (standard deviation)
    3.22 ( 1.9 )
    3.56 ( 2.52 )
    3.80 ( 2.37 )
    3.63 ( 2.59 )
    Statistical analysis title
    		 Mean difference placebo 1 - Tacrosolv 1
    Statistical analysis description
    A 95% confidence interval will be calculated for the mean difference between the active treatment and placebo from a two-sided paired t-test. We assume superiority of Tacrosolv versus Placebo. Superiority could be stated if the upper limit of the confidence interval does not exceed 0.
    Comparison groups
    Placebo 2 v Tacrosolv low-dose day 8
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.355
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 0.4
    Statistical analysis title
    		 mean difference placebo 2 - Tacrosolv 2
    Comparison groups
    Tacrosolv high-dose day 8 v Placebo 1
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.566
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.81

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs/SAEs will be recorded from the beginning of the study (signing consent form) up to the follow-up visit (end of trial).
    Adverse event reporting additional description
    Each subject will be monitored by the Investigator or study personnel for adverse events occurring throughout the study. During the treatment period, the Investigator or designee will inquire about AEs by asking the subject about changes in AEs or Concomitant medications.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Tacrosolv
    Reporting group description
    		 As it was a cross-over trial subjects received both treatment and placebo during the trial.

    Reporting group title
    Placebo
    Reporting group description
    		 As it was a cross-over design subjects received placebo and treatment during the trial.

    Serious adverse events
    		 Tacrosolv Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tacrosolv Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 64 (85.94%)
    20 / 64 (31.25%)
    Injury, poisoning and procedural complications
    Barotrauma
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    4 / 64 (6.25%)
    1 / 64 (1.56%)
         occurrences all number
    4
    1
    Migraine
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Eye disorders
    Abnormal sensation in eye
         subjects affected / exposed
    6 / 64 (9.38%)
    0 / 64 (0.00%)
         occurrences all number
    6
    0
    Asthenopia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Blepharitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    14 / 64 (21.88%)
    1 / 64 (1.56%)
         occurrences all number
    14
    1
    Eye irritation
         subjects affected / exposed
    30 / 64 (46.88%)
    6 / 64 (9.38%)
         occurrences all number
    30
    6
    Eye pruritus
         subjects affected / exposed
    9 / 64 (14.06%)
    5 / 64 (7.81%)
         occurrences all number
    9
    5
    Eyelid irritation
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    Eye swelling
         subjects affected / exposed
    5 / 64 (7.81%)
    1 / 64 (1.56%)
         occurrences all number
    5
    1
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Eyelids pruritus
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Lacrimation increased
         subjects affected / exposed
    14 / 64 (21.88%)
    1 / 64 (1.56%)
         occurrences all number
    14
    1
    Ocular discomfort
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    9 / 64 (14.06%)
    3 / 64 (4.69%)
         occurrences all number
    9
    3
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    9 / 64 (14.06%)
    1 / 64 (1.56%)
         occurrences all number
    9
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    • Small study group • Short observation period • Eye irritation due to Tacrolimus
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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
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