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    Summary
    EudraCT Number:2020-004126-32
    Sponsor's Protocol Code Number:T502-SIT-041
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2020-004126-32
    A.3Full title of the trial
    A prospective open follow-up study with 10 000 mTU/mL mannan-conjugated birch pollen allergoids administered subcutaneously to participants of the T502-SIT-020 trial
    Eine prospektive offene Folge-Studie mit 10 000 mTU/mL Mannan-konjugiertem Birkenpollen-Allergoid, welches subkutan den Teilnehmern der T502-SIT-020-Studie verabreicht wird
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective open follow-up study with 10 000 mTU/mL mannan-conjugated birch pollen allergoids administered subcutaneously to participants of the T502-SIT-020 trial
    Eine prospektive offene Folge-Studie mit 10 000 mTU/mL Mannan-konjugiertem Birkenpollen-Allergoid, welches subkutan den Teilnehmern der T502-SIT-020-Studie verabreicht wird
    A.4.1Sponsor's protocol code numberT502-SIT-041
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInmunotek S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInmunotek S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinCompetence Cologne GmbH
    B.5.2Functional name of contact pointContract Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Heuss-Ring 14
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50668
    B.5.3.4CountryGermany
    B.5.4Telephone number+492217161330
    B.5.5Fax number+4922171613329
    B.5.6E-mailregulatory@clincomptence.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameT502 10 000 mTU/mL
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNT502
    D.3.9.1CAS number 8000045-25-2
    D.3.9.2Current sponsor codeT502
    D.3.9.3Other descriptive nameALLERGENS, POLLEN & PLANT EXTRACT
    D.3.9.4EV Substance CodeSUB12787MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of birch pollen-induced allergic rhinitis or rhinoconjunctivitis
    Behandlung der durch Birkenpollen ausgelösten allergischen Rhinitis oder Konjunktivitis
    E.1.1.1Medical condition in easily understood language
    Treatment of patients who suffer from rhinitis or rhinoconjunctivitis due to birch pollen allergy
    Behandlung von Patienten, die an einem durch Birkenpollen ausgelösten allergischen Schnupfen oder allergischer Bindehautentzündung leiden
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to assess the clinical impact of the subcutaneous administration of Mannan conjugated polymerized birch pollen allergen extract in the concentration of 10 000 mTU/mL. The effect will be assessed by symptoms and medication need during the birch pollen season in April 2021.
    Das primäre Ziel dieser Studie ist die Beurteilung der klinischen Wirkung der subkanten Behandlung mit Mannan-konjugiertem, polymerisiertem Birkenpollen-Allergenextrakt in der Konzentration 10 000 mTU/mL bei Patienten mit einer durch Birkenpollen verursachten allergischen Rhinokonjunktivitis.
    Der Effekt wird durch die Entwicklung allergischer Symptome und den Bedarf an Bedarfsmedikation während der Birkenpollensaison im April 2021 bestimmt.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To assess the safety and clinical tolerability of the treatment with Mannan conjugated polymerized birch pollen allergen extract in the concentration of 10 000 mTU/mL.
    - To assess the impact of the treatment with Mannan conjugated polymerized birch pollen allergen extract in the concentration of 10 000 mTU/mL on the immunological status of the patients.
    - To assess the clinical impact of the treatment with Mannan conjugated polymerized birch pollen allergen extracts in the concentration of 10 000 mTU/mL with regard to health-related Quality of Life.
    - To assess the clinical impact of the subcutaneous administration of mannan conjugated polymerized birch pollen allergen extract in the concentration of 10 000 mTU/mL in further treatment in 2021/2022. The effect will be assessed by symptoms and medication need during the birch pollen season in April 2022 and 2023.
    Die sekundären Ziele dieser Studie sind:
    • die Bewertung der Sicherheit und der klinischen Verträglichkeit der Behandlung mit Mannan-konjugiertem, polymerisiertem Birkenpollen-Allergenextrakt in der Konzentration 10 000 mTU/mL,
    • die Wirkung von Mannan-konjugiertem, polymerisiertem Birkenpollen-Allergenextrakt in der Konzentration 10 000 mTU/mL auf den immunologischen Status der Patienten
    • die Bewertung der klinischen Wirkung von Mannan-konjugiertem, polymerisiertem Birkenpollen-Allergenextrakt in der Konzentration 10 000 mTU/mL auf die Lebensqualität,
    • die Bewertung der klinischen Wirkung der subkutanen Weiterbehandlung in 2021/2022 mit Mannan-konjugiertem, polymerisiertem Birkenpollen-Allergenextrakt in der Konzentration 10 000 mTU/mL. Der Effekt wird durch die Entwicklung allergischer Symptome und den Bedarf an der Bedarfsmedikation der Birkenpollensaisons im April 2022 und 2023 bestimmt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated Informed Consent Form by a legally competent patient,
    • Participation in the T502-SIT-020 trial,
    • Being in good physical and mental health,
    • Confirmed normal renal and liver function, including non-clinically significant deviations outside the reference ranges (< grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit*),
    • For females: non-pregnant, non-lactating with adequate contraception, or females unable to bear children (i.e. tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)),
    • For asthmatic patients: confirmed diagnosis of controlled asthma during the treatment period according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014)
    • FEV1 ≥ 80% of the patient’s reference value or Peak Expiratory Flow (PEF) ≥ 80% of the patients´ individual optimal value (for asthmatic patients only)
    • Unterschriebene und datierte Einwilligungserklärung des Patienten
    • Teilnahme an der Studie T502-SIT-020
    • Patienten in gutem körperlichen und mentalen Zustand gemäß ihrer Anamnese und Vitalparameter
    • Patienten mit bestätigten normalen Nieren- und Leberfunktionen, einschließlich nicht- klinisch signifikanter Abweichungen entsprechend der Normwerttabelle (< Grad 2 gemäß „FDA Guidance for Industry for preventive Vaccine Trials“ (FDA, 2007)),
    • Nicht schwangere, nicht stillende Frauen mit einer adäquaten Schwangerschafts-verhütung bzw. Frauen, die keine Kinder bekommen können (z. B. Tubenligatur, Hysterektomie oder Post-Menopause (die letzte Regelblutung liegt länger als ein Jahr zurück))
    • Asthmatische Patienten: Teilnahme ausschließlich für Patienten mit einer bestätigten Diagnose eines kontrollierten Asthmas gem. GINA Leitlinie Stufe 1-3, GINA 2014
    • Forced Expiratory Flow (FEV1) -Wert ≥ 80% des Referenzwertes oder Peak Expiratory Flow (PEF) ≥ 80% des individuellen Bestwertes (nur für asthmatische Patienten).
    E.4Principal exclusion criteria
    • Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion,
    • No participation in the T502-SIT-020 study
    • Ongoing immunotherapy with birch pollen allergens or any other allergens,
    • Being in any relationship or dependence with the Sponsor, CRO and/or Investigator,
    • Inability to understand instructions/study documents,
    • Patients who do not have access to a smartphone/tablet (iOS or Android)#
    • History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.,
    • History of hypersensitivity to the excipients of the investigational product or placebo,
    • Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014) during the treatment period,
    • Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient’s reference value (ECSC) or Peak Expiratory Flow (PEF) < 80% of the patients´ individual optimal value,
    • History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening,
    • Patients who have suspicion or symptoms of a SARS-COV-2 infection, who have had contact with a confirmed case of COVID-19, or returned from a COVID-19 risk region in the 2 weeks prior to the screening visit.
    • Patients with acute allergic rhinoconjunctivitis due to other environmental allergens during the study period,
    • History of significant renal disease or chronic hepatic disease,
    • Malignant active disease (ongoing or within the five past years),
    • Severe autoimmune disease,
    • Immune defects including immunosuppression, immunopathies
    • Vaccination during the treatment periods DEC 2020 - MAR 2021 and DEC 2021 - MAR 2022 except Influenza and SARS-CoV-2 vaccinations – see Chapter XII.2 ‘Non-allowed drugs and procedures’
    • Use of systemic immunosuppressive medications (e.g. methotrexate or cyclosporine A) or blood transfusion one month before screening,
    • General inflammatory, severe acute or chronic inflammatory diseases,
    • Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
    • Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.),
    • Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents,
    • Intake of beta-blockers/ACE inhibitor medication (angiotensin-converting enzyme inhibitor),
    • Active tuberculosis,
    • Having any contraindication for the use of adrenaline (including hyperthyroidism),
    • Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus,
    • Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method which is defined in chapter VI.1 ‘Inclusion Criteria’,
    • Administration of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within the time period preceding the trial (screening visit), as defined in the protocol, exception made for routine (previously prescribed) control medication for asthmatic patients,
    • Clinically relevant laboratory values, i.e. grade ≥ 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit*,
    • Patients that the Investigator believes will not comply with the study protocol (patients with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol).

    #In exceptional cases, a paper diary may be provided.
    • Gleichzeitige Teilnahme an anderen klinischen Prüfungen oder vorangegangene Teilnahme an einer klinischen Prüfung innerhalb der letzten 30 Tage vor Einschluss in die vorliegende Studie
    • Keine Teilnahme an der Studie T502-SIT-020
    • Andauernde Immuntherapie gegen andere Allergene
    • Patienten, die in irgendeiner Beziehung oder Abhängigkeit zum Sponsor, CRO und/oder Prüfarzt stehen
    • Unfähigkeit, die Anweisungen/Studiendokumente zu verstehen
    • Patienten, die keinen Zugang zu einem Smartphone/Tablet haben (iOS oder Android Betriebssystem)#
    • Patienten mit einer bekannten vorangegangenen Anaphylaxie, inklusive Nahrungsmittel (z.B. Erdnuss oder Meerestiere) oder Hautflügler-Gift (z. B. Bienen- oder Wespenstiche) oder Medikamente (z. B. Penicillin)
    • Patienten mit einer bekannten Überempfindlichkeit gegenüber Bestandteilen des Prüfpräparats
    • Patienten mit geringgradig persistierendem bis schwergradig persistierendem Asthma, halb kontrolliertem oder unkontrolliertem Asthma gem. GINA Leitlinie (GINA 2014) während der Behandlungsphase
    • Chronisches Asthma oder Emphysem, insbesondere mit einem FEV 1 < 80% des erwarteten Wertes (ECSC) oder mit einem Peak Expiratory Flow-Wert < 80% des individuellen Bestwertes
    • Patienten mit einer Anamnese einer Atemwegsinfektion und / oder Verschlimmerung von Asthma innerhalb von 4 Wochen vor dem Screening
    • Patienten mit Verdacht oder Symptomen einer SARS-COV-2-Infektion, die Kontakt zu einem bestätigten Fall von COVID-19 hatten oder in den 2 Wochen vor dem Screening-Besuch aus einer COVID-19-Risikoregion zurückgekehrt sind.
    • Patienten mit akuten allergischen Symptomen gegenüber anderen Umweltallergenen während der Dauer der Studie
    • Patienten mit einer Anamnese einer schweren Nierenerkrankung oder einer chronischen Lebererkrankung
    • Patienten mit aktiv malignen Erkrankungen (andauernd oder innerhalb der letzten 5 Jahre)
    • Patienten mit einer bekannten schweren Autoimmun-Erkrankung
    • Patienten mit Immundefekten incl. Immunsuppression und Immunopathien
    • Patienten, welche Impfungen während des Behandlungszeitraumes (Dez. 2020-Mär. 2021 und Dez. 2021-Mär. 2022) benötigen ausgenommen die Grippeschutzimfpung und SARS-CoV-2 Impfungen
    • Patienten, welche systemische immunsuppressive Medikamente (z. B. Methotrexat oder Cyclosporin A) oder Bluttransfusionen einen Monat vor dem Screening benötigt haben
    • Patienten mit allgemein-inflammatorischen, oder schweren, akuten oder chronisch inflammatorischen Erkrankungen
    • Patienten mit chronischen Krankheiten, die die Eignung des Patienten für die Teilnahme an dieser Studie beeinträchtigen (z.B. schwere kongestive Herzinsuffizienz, aktives Magengeschwür, entzündliche Darmerkrankung, unkontrollierter Diabetes mellitus etc.)
    • Patienten, die Antidepressiva mit starken Antihistamin-Eigenschaften einnehmen (trizyklische Antidepressiva, z.B. Doxepin, Amitriptylin, Desipramin, Imipramin etc.)
    • Patienten, die mit anti-IgE-Antikörpern, Mastzellstabilisatoren oder Anti-Leukotrienen behandelt werden
    • Patienten, die systemische Beta-Blocker oder ACE-Hemmer (angiotensin-converting enzyme) einnehmen
    • Patienten mit aktiver Tuberkulose
    • Patienten mit einer Kontraindikation für die Anwendung von Adrenalin (incl. Hyperthyroidismus)
    • Patienten mit bereits bekanntem, positivem Test für Humanes Immundefizienz-Virus (HIV-1/2), Hepatitis B Virus (HBV) oder Hepatitis C Virus (HCV)
    • Schwangere, stillende oder gebärfähige Frauen ohne adäquate Schwangerschafts-verhütung
    • Einnahme von Kortikoiden (oral, topisch oder nasal) oder von Antihistaminika innerhalb des definierten Zeitraumes vor Studienbeginn (Voruntersuchung V1)
    • Patienten mit klinisch signifikanten Laborwerten größer als Grad 2 gemäß „FDA Guidance for Industry for preventive Vaccine Trials“ (FDA, 2007)
    • Unzuverlässige Patienten, Patienten mit bekannter Alkoholabhängigkeit oder Medikamenten-Missbrauch oder ernsthafter psychiatrischer Erkrankung sowie Patienten, die die Patienteneinverständniserklärung nicht unterschreiben möchten oder Patienten, die die Vorgaben des Studienprotokolls nicht befolgen

    #In Ausnahmefällen kann ein Papiertagebuch zur Verfügung gestellt werden.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    The clinical impact of the treatment with mannan conjugated polymerized birch pollen allergen extract in the concentration 10 000 mTU/mL will be assessed by the Combined Symptom and Medication Score (CSMS) over the peak pollen period in 2021.
    Primärer Endpunkt
    Die klinische Bedeutung der Behandlung mit Mannan-konjugiertem, polymerisiertem Birkenpollen-Allergenextrakt in der Konzentration 10 000 mTU/mL wird durch den Vergleich des kombinierten Symptom-Medikationsscore (CSMS) während des Höhepunktes der Birkenpollen-Saison 2021 bestimmt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The Combined Symptom and Medication Score (CSMS) will be evaluated over the peak birch pollen period 2021.
    Der Symptom-Medikationsscore (CSMS) wird während des Höhepunktes der Birkenpollen-Saison 2021 bestimmt.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    The safety and clinical tolerability assessment of the treatment with the Mannan conjugated polymerized birch pollen allergen extract in the concentration 10 000 mTU/mL will be assessed by:
    - Solicited adverse events
    o Local reactions at the injection site (wheal and redness)
    o Systemic allergic reactions after administration of the investigational product
    - Unsolicited adverse events and serious adverse events
    - Physical examinations and vital signs
    - Laboratory investigations (blood count, clinical chemistry, renal and liver function-related parameters)
    - Pulmonary function testing for asthmatic patients
    - Use of rescue medication during treatment phases 2020/2021 and 2021/2022.

    Clinical immunogenicity endpoints will include:
    - Induction of birch pollen-specific immuno-globulins IgE, IgG and IgG4

    Clinical impact endpoints will include:
    - The Combined Symptom and Medication Score (CSMS) over the peak birch pollen seasons 2022 and 2023
    - The Combined Symptom and Medication Score (CSMS) over the birch pollen seasons in April 2021, 2022 and 2023
    - The mean daily Symptom Score (dSS) over the birch peak pollen season and the birch pollen seasons in April 2021, 2022 and 2023
    - The mean daily Medication Score (dMS) over the birch peak pollen season and the birch pollen seasons in April 2021, 2022 and 2023
    Sekundäre Endpunkte:
    Die Sicherheit und Verträglichkeit von Mannan-konjugiertem, polymerisiertem Birkenpollen-Allergenextrakt in der Konzentration 10 000 mTU/mL werden bestimmt durch:
    - Erwartete unerwünschte Ereignisse
    o Lokalreaktionen an der Injektionsstelle (Quaddel und Rötung)
    o Allergische systemische Reaktionen nach Verabreichung der Prüfmedikation.
    - Unerwartete unerwünschte Ereignisse und schwere unerwünschte Ereignisse
    - Körperliche Untersuchung und Vitalfunktionen
    - Laboruntersuchungen (Hämatologie, klinische Chemie, Tests zur Nieren- und Leberfunktion)
    - Lungenfunktionstests bei asthmatischen Patienten
    - Verwendung von Notfallmedikation während der Behandlungsphasen 2020/2021 und 2021/2022.

    Der immunologische Status der Patienten wird erfasst durch:
    - Die Produktion von Birkenpollen-spezifischem IgE, IgG und IgG4.

    Die klinische Wirksamkeit der Behandlung wird erfasst durch:
    - Den kombinierten Symptom- und Medikations-Score (CSMS) über die Birkenpollen Hochsaisons 2022 und 2023
    - Den kombinierten Symptom- und Medikations-Score (CSMS) über die Birkenpollensaison im April 2021, 2022 und 2023
    - Den mittleren täglichen Symptom-Score (dSS) während des Höhepunkts und der Birkenpollensaison im April 2021, 2022 und 2023
    - Den mittleren täglichen Medikations-Score (dMS) während des Höhepunkts und der Birkenpollensaison im April 2021, 2022 und 2023
    E.5.2.1Timepoint(s) of evaluation of this end point
    Solicited AEs will be evaluated between V2 - V7 and V10 - V15, unsolicited AEs and SAEs between V1 and V20.
    Physical examinations and vital signs will be evaluated between V1 - V20.
    Safety laboratory investigations will be done at V1 and V7.
    The use of rescue medication during the treatment phase will be evaluated between V2 - V6 and V10 - V14.
    Immunogenicity endpoints will be measured at V1, V7, V10, V15 and V18.
    CSMS will be evaluated over the pollen seasons in April 2021, 2022 and 2023.
    RQLQ will be evaluated at V7, V8, V15, V16, V18 and V19.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months32
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months32
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 199
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients with ongoing symptoms due to birch pollen-induced rhinitis or rhinoconjunctivitis will be treated following this trial by their physician according to the guidelines.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-06
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