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    Clinical Trial Results:
    A multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Birch Modified Allergen Tyrosine adsorbed + MPL in the prevention of seasonal symptoms in subjects with allergic rhinoconjunctivitis due to birch pollen

    Summary
    EudraCT number
    		 2016-002781-31
    Trial protocol
    		 DE   AT   SE   PL  
    Global end of trial date
    20 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Apr 2021
    First version publication date
    04 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PQBirch301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergy Therapeutics (UK) Ltd.
    Sponsor organisation address
    Dominion Way, Worthing, United Kingdom, BN14 8SA
    Public contact
    Clinical Research Management, Bencard Allergie GmbH, +49 08936811436, pqbirch301@allergytherapeutics.com
    Scientific contact
    Clinical Research Management, Allergy Therapeutics (UK) Ltd., +49 08936811436, pqbirch301@allergytherapeutics.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
    03 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of PQ Birch in birch pollen-induced rhinoconjunctivitis.
    Protection of trial subjects
    The conduct of this trial met all local legal and regulatory requirements. The study was conducted in accordance with the principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Guideline E6: Good Clinical Practice (GCP). An informed consent form explaining the procedures of the study including the potential hazards was reviewed and approved by the responsible IEC/IRB before its use.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2017
    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
    Poland: 147
    Country: Number of subjects enrolled
    Sweden: 51
    Country: Number of subjects enrolled
    Austria: 51
    Country: Number of subjects enrolled
    Germany: 333
    Worldwide total number of subjects
    582
    EEA total number of subjects
    582
    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)
    582
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 58 investigational sites in four countries: Austria, Germany, Poland and Sweden. Overall, 945 patients were screened and 582 patients were randomised and received the study medication.

    Pre-assignment
    Screening details
    		 Male or female aged 18 to 60 years with a positive history of moderate to severe seasonal allergic rhinoconjunctivitis ascribed to birch pollen exposure requiring anti-allergic treatment for symptom control for at least two consecutive seasons prior to study.

    Period 1
    Period 1 title
    Visit 2 - 7 (Visits 1 = Screening) (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
    Blinding implementation details
    The identity of study medication administered was not known by the subject, investgators or other persons directly involved in the conduct of the clinical study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 6 subcutaneous injections of Placebo given sequentially at weekly intervals
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trained site personnel administered 6 subcutaneous injections of 1.0 mL each in eligible subjects in the outer third part of the upper arm.

    Arm title
    		 PQ Birch
    Arm description
    		 6 subcutaneous injections of PQ Birch 900, 2400, 6000, 6000, 6000 and 6000 SU sequentially to achieve a cumulative dose of 27300 SU
    Arm type
    		 Experimental

    Investigational medicinal product name
    PQ Birch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trained site personnel administered 6 subcutaneous injections of 1.0 mL each in eligible subjects in the outer third part of the upper arm.

    Number of subjects in period 1
    		Placebo PQ Birch
    Started
    283
    299
    Completed
    275
    282
    Not completed
    8
    17
         Consent withdrawn by subject
    2
    6
         Physician decision
    -
    1
         N/A
    1
    -
         Adverse event, non-fatal
    1
    7
         Non-compliance to study drug
    1
    -
         Failure to meet randmization criteria
    1
    1
         Lost to follow-up
    2
    -
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 6 subcutaneous injections of Placebo given sequentially at weekly intervals

    Reporting group title
    PQ Birch
    Reporting group description
    		 6 subcutaneous injections of PQ Birch 900, 2400, 6000, 6000, 6000 and 6000 SU sequentially to achieve a cumulative dose of 27300 SU

    Reporting group values
    		 Placebo PQ Birch Total
    Number of subjects
    		 283 299 582
    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)
    		 283 299 582
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.8 ( 11.5 ) 36.6 ( 10.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 145 154 299
        Male
    		 138 145 283
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) consists of all patients that received at least one injection of study medication. The analysis will follow the intention-to-treat principle and will analyse patients according to the treatment group that they were randomised to, regardless of any errors in the administration of treatment.

    Subject analysis set title
    PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol set (PPS) is a subset of the FAS and excludes all patients with major protocol violations that affect the evaluation of the primary endpoint of the study.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set will consist of all patients who received at least one injection of study medication. Patients will be analysed according to the treatment they actually received.

    Subject analysis sets values
    		 FAS PPS Safety Set
    Number of subjects
    582
    501
    582
    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)
    582
    501
    582
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.2 ( 11.2 )
    37.3 ( 11.0 )
    37.2 ( 11.2 )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 6 subcutaneous injections of Placebo given sequentially at weekly intervals

    Reporting group title
    PQ Birch
    Reporting group description
    		 6 subcutaneous injections of PQ Birch 900, 2400, 6000, 6000, 6000 and 6000 SU sequentially to achieve a cumulative dose of 27300 SU

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) consists of all patients that received at least one injection of study medication. The analysis will follow the intention-to-treat principle and will analyse patients according to the treatment group that they were randomised to, regardless of any errors in the administration of treatment.

    Subject analysis set title
    PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol set (PPS) is a subset of the FAS and excludes all patients with major protocol violations that affect the evaluation of the primary endpoint of the study.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set will consist of all patients who received at least one injection of study medication. Patients will be analysed according to the treatment they actually received.

    Primary: N/A

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    End point title
    		 N/A [1]
    End point description
    End point type
    Primary
    End point timeframe
    Visit 2-7
    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: Following discussions with Paul-Ehrlich-Institute, it was agreed to invalidate the primary efficacy endpoint and all secondary efficacy endpoints related to eDiary data.
    End point values
    		 Placebo PQ Birch
    Number of subjects analysed
    283
    299
    Units: NA
    283
    299
    No statistical analyses for this end point

    Secondary: Frequency, severity and relationship of AEs

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    End point title
    		 Frequency, severity and relationship of AEs
    End point description
    Overall summary of frequency, severity and relationship of adverse events during study duration
    End point type
    Secondary
    End point timeframe
    Visit 2-7
    End point values
    		 Placebo PQ Birch Safety Set
    Number of subjects analysed
    283
    299
    582
    Units: Subjects
    282
    300
    582
    Attachments
    		 Untitled (Filename: Frequency, severity and relationship of AEs.pdf)
    No statistical analyses for this end point

    Secondary: ARCs

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    End point title
    		 ARCs
    End point description
    ARCs: Local and sytemic TEAE within 24 hours of injection
    End point type
    Secondary
    End point timeframe
    Visit 2-7
    End point values
    		 Placebo PQ Birch Safety Set
    Number of subjects analysed
    283
    299
    582
    Units: Subjects
    282
    299
    582
    Attachments
    		 Untitled (Filename: ARCs.pdf)
    No statistical analyses for this end point

    Secondary: AEs leading to premature discontinuation of treatment

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    End point title
    		 AEs leading to premature discontinuation of treatment
    End point description
    AEs leading to premature discontinuation of treatment
    End point type
    Secondary
    End point timeframe
    Visit 2-7
    End point values
    		 Placebo PQ Birch Safety Set
    Number of subjects analysed
    283
    299
    582
    Units: Subjects
    282
    300
    582
    Attachments
    		 Untitled (Filename: AE to premature discontinuation of treatment.pdf)
    No statistical analyses for this end point

    Secondary: Laboratory changes

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    End point title
    		 Laboratory changes
    End point description
    Laboratory changes (serum chemistry, hematology, urinanalysis): changes screening - final visit
    End point type
    Secondary
    End point timeframe
    Screening - final visit
    End point values
    		 Placebo PQ Birch Safety Set
    Number of subjects analysed
    283
    299
    582
    Units: Subjects
    282
    299
    582
    Attachments
    		 Untitled (Filename: Laboratory changes.pdf)
    No statistical analyses for this end point

    Secondary: Vital signs

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    End point title
    		 Vital signs
    End point description
    Vital signs evaluation
    End point type
    Secondary
    End point timeframe
    Baseline - final visit
    End point values
    		 Placebo PQ Birch Safety Set
    Number of subjects analysed
    283
    299
    582
    Units: Subjects
    282
    300
    582
    Attachments
    		 Untitled (Filename: Vital signs.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within the time period from the first injection of study medication until Visit 7.
    Adverse event reporting additional description
    AEs were summarised by treatment group and primary SOC, preferred term, additionally by causality assessment and intensity 8 serious AE were reported, 4 during pre-treatment and 4 during treatment period. None of these AEs were related to the treatment. None of these serious AEs were serious adverse drug reactions.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    PQ Birch
    Reporting group description
    		 Safety Set Evaluation data presented

    Reporting group title
    Placebo
    Reporting group description
    		 Safety Set Evaluation data presented

    Serious adverse events
    		 PQ Birch Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 300 (2.00%)
    2 / 282 (0.71%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Meniscus injury
    Additional description: Reported in treatment period, not related to treatment, no ADR
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
    Additional description: Reported in treatment period, not related to treatment, no ADR
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
    Additional description: Reported in pre-treatment period, not related to treatment, no ADR
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
    Additional description: Reported in pre-treatment period, not related to treatment, no ADR
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Palpitations
    Additional description: Reported in pre-treatment period, not related to treatment, no ADR
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 282 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
    Additional description: Reported in pre-treatment period, not related to treatment, no ADR
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
    Additional description: Reported in treatment period, not related to treatment, no ADR
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 282 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
    Additional description: Reported in treatment period, not related to treatment, no ADR
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 282 (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
    		 PQ Birch Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    229 / 300 (76.33%)
    140 / 282 (49.65%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 300 (8.33%)
    14 / 282 (4.96%)
         occurrences all number
    50
    23
    General disorders and administration site conditions
    Injection site swelling
         subjects affected / exposed
    155 / 300 (51.67%)
    50 / 282 (17.73%)
         occurrences all number
    408
    89
    Injection site erythema
         subjects affected / exposed
    119 / 300 (39.67%)
    28 / 282 (9.93%)
         occurrences all number
    331
    46
    Injection site pain
         subjects affected / exposed
    89 / 300 (29.67%)
    57 / 282 (20.21%)
         occurrences all number
    212
    123
    Injection site pruritus
         subjects affected / exposed
    94 / 300 (31.33%)
    11 / 282 (3.90%)
         occurrences all number
    265
    19
    Injection site warmth
         subjects affected / exposed
    31 / 300 (10.33%)
    5 / 282 (1.77%)
         occurrences all number
    58
    7
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    84 / 300 (28.00%)
    54 / 282 (19.15%)
         occurrences all number
    109
    67

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Aug 2017
    Protocol (Version 5.0) and respective documents updated

    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
    For support, Contact us.
    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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