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    Summary
    EudraCT Number:2015-002409-13
    Sponsor's Protocol Code Number:AL1501AV
    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:2015-08-28
    Trial results View 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 number2015-002409-13
    A.3Full title of the trial
    A multicenter, randomized, open-label clinical trial to evaluate safety and tolerability of a year-round initiation of specific immunotherapy with an aluminum hydroxide adsorbed allergoid preparation of 6-grasses in patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma.
    Eine multizentrische, randomisierte, offene klinische Studie zur Evaluierung der Sicherheit und Verträglichkeit einer ganzjährigen Aufdosierung einer spezifischen Immuntherapie mit einem Aluminiumhydroxid adsorbierten Allergoid von 6 Gräsern in Patienten mit moderater bis schwerer saisonaler Rhinitis oder Rhinokonjunktivities mit oder ohne kontrolliertem Asthma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study conducted in several test centres to investigate the safety and tolerability of a year-round dosage of immune therapy with an Allergoid drug in patients with hay fever and or without controlled asthma.
    Eine klinische Studie die in mehreren Prüfzentren durchgeführte um die Sicherheit und Verträglichkeit einer ganzjährigen Aufdosierung einer Immuntherapie mit einem Allergoid Medikament in Patienten mit Heuschnupfen und oder ohne kontrolliertem Asthma zu untersuchen.
    A.3.2Name or abbreviated title of the trial where available
    SuBITo
    SuBITo
    A.4.1Sponsor's protocol code numberAL1501AV
    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 SponsorAllergopharma GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAllergopharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergopharma GmbH & Co. KG
    B.5.2Functional name of contact pointPD Dr. med Dietrich Häfner
    B.5.3 Address:
    B.5.3.1Street AddressHermann-Körner-Str. 52
    B.5.3.2Town/ cityReinbek
    B.5.3.3Post code21465
    B.5.3.4CountryGermany
    B.5.4Telephone number00494072765316
    B.5.5Fax number00494072765600
    B.5.6E-maildietrich.haefner@allergopharma.com
    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 Yes
    D.2.1.1.1Trade name Allergovit® Grasses
    D.2.1.1.2Name of the Marketing Authorisation holderAllergopharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAllergovit® Grasses
    D.3.2Product code 553a/91a-b
    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 INNAllergovit® grasses
    D.3.9.1CAS number 8000045-25-2
    D.3.9.3Other descriptive nameALLERGENS, POLLEN & PLANT EXTRACT
    D.3.9.4EV Substance CodeSUB12787MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 6000
    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
    Patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma.
    Patienten mit moderater bis schwerer saisonaler Rhinitis oder Rhinokonjunktivities mit oder ohne kontrolliertem Asthma.
    E.1.1.1Medical condition in easily understood language
    Patients suffering from hay fever with or without asthma during the grass pollen season.
    Patienten mit Heuschnupfen, mit oder ohne Asthma, während der Gräserpollensaison.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10039776
    E.1.2Term Seasonal allergic rhinitis
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001726
    E.1.2Term Allergic rhinitis due to pollen
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this therapeutic phase IIIb trial is to evaluate the safety and tolerability of a year-round initiation start of immunotherapy with Allergovit® 6-grasses in patients with rhinitis or rhinoconjunctivitis, caused by grasses, with or without controlled allergic asthma compared to a standard therapy.
    A possible influence (masking of adverse events) of a symptomatic co-medication during intraseasonal therapy will be considered.
    Das Hauptziel dieser therapeutischen Phase-IIIb-Studie ist die Untersuchung der Sicherheit und Verträglichkeit einer ganzjährig initiierten Immuntherapie mit Allergovit ® 6-Gräser in Patienten mit Rhinoconjunctivitis, verursacht durch Gräser, mit oder ohne kontrolliertes allergisches Asthma zu untersuchen und mit einer Standard Therapie zu vergleichen.
    Ein möglicher Einfluss (Maskierung der unerwünschten Ereignisse) einer symptomatischen Co-Medikation während der intraseasonal Therapie wird berücksichtigt.
    E.2.2Secondary objectives of the trial
    Not applicable.
    Nicht zutreffend.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent given according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient).
    2. Legally competent male or female outpatient
    3. Age ≥ 18 and ≤ 65 years
    4. IgE-mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without controlled allergic asthma caused by grass pollen as confirmed by the following test procedures:
    • Skin prick test (SPT):
    • wheal for 6-grasses pollens ≥ 3 mm in diameter
    • Histamine wheal ≥ 3 mm (positive control)
    • NaCl reaction < 2 mm (negative control)
    • Immunoassay result for specific IgE ≥ 0.70 kU/L to grass mix/earlybloom (central lab)
    5. Main symptoms of allergic rhinitis or rhinoconjunctivitis between the months of May to August of at least 1 month with respective grass pollen exposure in the previous 2 seasons
    6. Previous treatment with anti-allergic treatment for at least 2 seasons prior to enrolment
    1. Hat der Patient vor der Durchführung irgendwelcher studienbezogener Verfahren seine Einwilligung gemäß den regulatorischen Anforderungen erteilt? (Ein studienbezogenes Verfahren ist jedes Verfahren, das bei einer routinemäßigen Behandlung des Patienten nicht durchgeführt worden wäre.)
    2. Ist der männliche oder weibliche ambulante Patient im rechtlichen Sinne geschäftsfähig
    3. Patient ist ≥ 18 and ≤ 65 Jahre alt
    4. Leidet der Patient an einer IgE-vermittelten saisonalen allergischen Rhinokonjunktivitis mit oder ohne kontrolliertes Asthma bronchiale verursacht durch Gräserpollen und erfüllt folgende Kriterien
    • Haut-Prick-Test:
    • Haut-Prick-Test Quaddel für 6-Gräserpollen Allergen ≥ 3 mm Durchmesser
    • Histamine Quaddel ≥ 3 mm (Positive Kontrolle)
    • NaCl Kontrollreaktion < 2 mm (Negative Kontrolle)
    • Immunoassay Ergebnisse für spezifisches IgE ≥ 0.70 kU/L für Gräsermischung/Frühblüher (Zentral Labor)
    5. Hauptbeschwerden aufgrund von allergischer Rhinokonjunktivitis in den Monaten Mai bis August mit mindestens 1 Monat Gräserpollen Exposition in den letzten 2 Saisons.
    6. Behandlung mit einem Antiallergikum in den letzten 2 Saisons vor der Aufnahme in die Studie.
    E.4Principal exclusion criteria
    General criteria:
    1. Unable to understand and comply with the requirements of the trial, as judged by the investigator
    2. Currently participating in any other trial or participating in any other trial within 30 days before inclusion into this trial
    3. Low compliance or inability to understand instructions/trial documents
    4. Involvement in the planning and conduct of the trial
    5. Employee of Allergopharma GmbH & Co. KG or of one of the trial sites or any relationship with the sponsor or investigator
    6. Mentally disabled
    7. Institutionalized due to an official or judicial order
    For females with childbearing potential (i.e. females who are not chemically or surgically sterilized or females who are not postmenopausal):
    8. Positive pregnancy test at screening or during the course of the trial
    9. Use of an unacceptable or unreliable contraceptive method during the trial, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year)
    10. Wish to breastfeed
    11. Wish to become pregnant during the course of the trial

    Immunotherapy criteria:
    12. AIT with grass pollen within the last 5 years
    13. Currently under any sort of immunotherapy
    14. AIT with unknown allergen within the last 5 years

    Diseases and health status:
    15. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
    16. Peak expiratory flow (PEF) < 70% of predicted normal (ECSC) under adequate asthma treatment according to GINA 2015
    17. Uncontrolled or partly controlled asthma according to GINA 2015
    18. Perennial and continuously treated asthma
    19. Rhinoconjunctival atopic symptoms for 20 years or longer
    20. Severe acute or chronic diseases (e.g. active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)
    21. Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease)
    22. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
    23. Recurrent seizures
    24. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
    25. Laboratory values greater than Grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials)
    Medications:
    26. Use of beta-blockers (locally or systemically)
    27. Contraindication for use of adrenaline (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension)
    28. Completion or ongoing treatment with anti-IgE-antibody
    29. Completion or ongoing long-term treatment with tranquilizer or other psychoactive drugs
    30. Use of prophylactic or continuous treatment with anti-allergic medication in fixed (constant) dose during the pollen season
    Allgemeine Kriterien:
    1. Ist der Patient nach Meinung des Prüfarztes nicht in der Lage, die Studienanforderungen zu verstehen und zu erfüllen
    2. Nimmt der Patient zurzeit an einer anderen Studie teil oder hat er innerhalb von 30 Tagen vor Aufnahme in diese Studie an einer anderen Studie teilgenommen
    3. Geringe Compliance oder Unfähigkeit, Anweisungen bzw. die Studiendokumente zu verstehen
    4. Beteiligung an der Planung und Durchführung der Studie
    5. Mitarbeiter von Allergopharma GmbH & Co. KG oder eines der Prüfzentren oder irgendeine Abhängigkeitsbeziehung zu dem Sponsor oder dem Prüfarzt
    6. Geistige Behinderung
    7. Befindet sich der Patient aufgrund einer behördlichen oder richterlichen Anordnung in einer Anstalt
    Für Frauen, die schwanger werden können (d. h. Frauen, die nicht chemotherapeutisch verhüten, operativ sterilisiert wurden oder Frauen, die nicht postmenopausal sind):
    8. Positiver Schwangerschaftstest bei Einschluss oder während des Studienverlaufs
    9. Verwendet die Patientin während der Studie nach Meinung des Prüfarztes eine nicht anerkannte und unzuverlässige Form der Empfängnisverhütung (anerkannte und zuverlässige Form der Empfängnisverhütung mit einer niedrigen Versagensrate d.h. weniger als 1 % pro Jahr)
    10. Hat die Patientin vor zu stillen
    11. Plant die Patientin, während der Studie schwanger zu werden

    Kriterien der Immuntherapie:
    12. Immuntherapie mit Gräserpollen innerhalb der letzten 5 Jahre
    13. Gegenwärtig mit einer Immuntherapie jeglicher Art behandelt
    14. Immuntherapie mit unbekannten Allergenen innerhalb der letzten 5 Jahre

    Krankheiten und Gesundheitszustand:
    15. Klinisch relevante chronische rhinokonjunktivale oder respiratorische Symptome aufgrund anderer Ursachen als Allergie
    16. Atemfluss (PEF) < 70% des vorhergesagten Normalwertes (ECSC) unter adäquater Asthma Behandlung gemäß GINA 2015
    17. Unkontrolliertes oder teilweise kontrolliertes Asthma gemäß GINA Leitlinien 2015
    18. Ganzjährig und fortwährend behandlungsbedürftiges Asthma
    19. Seit mehr als 20 Jahren oder länger rhinokonjunktivalen Atopiesymptome
    20. Schwere akute oder chronische Krankheiten (z. B. aktive Tuberkulose, Diabetes mellitus Typ I, maligne Neoplasie, chronische Niereninsuffizienz) oder schwere entzündliche Erkrankungen (Leber, Niere)
    21. Autoimmunkrankheiten, Immundefekte inklusive Immunsuppression, immunkomplexinduzierte Immunopathien (z. B. HIV, Patienten nach Transplantation, Lupus erythematodes [SLE], Vitiligo Morbus Basedow)
    22. Schwere psychiatrische oder psychologische Störungen mit Kooperationsbeeinträchtigung (z. B. Alkohol- oder Drogen-/Medikamentenmissbrauch)
    23. Rezidivierenden Krampfanfälle
    24. Irreversible sekundäre Änderung am reaktiven Organ (z.B. Emphysema, Bronchiektasie)
    25. Laborwert mit einem Schweregrad höher als 1 gemäß der FDA-Leitlinien für die Industrie („Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials“)

    Medikamente:
    26. Beta-Blocker Behandlung (lokal und systemisch)
    27. Kontraindikationen für eine Adrenalinanwendung (z. B. akute oder chronische symptomatische koronare Herzerkrankung, schwerer Bluthochdruck)
    28. Abgeschlossene oder laufende Therapie mit Anti-IgE-Antikörpern
    29. Gegenwärtig oder Langzeitbehandlung mit Beruhigungsmitteln oder anderen Psychopharmaka
    30. Verwendung einer prophylaktischen oder laufenden Behandlung mit Anti-Allergischen Medikation in einer festen (konstanten) Dosis während der Pollensaison
    E.5 End points
    E.5.1Primary end point(s)
    The aim of the trial is to obtain information about the safety and tolerability of an intraseasonal compared to a standard dose escalation of Allergovit® 6-grasses.
    To achieve this goal, the following safety variables will be assessed:
    • the incidence, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term,
    • the incidence, type and intensitiy of AEs assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term,
    • the incidence, type and intensity of local AEs assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term,
    • the incidence and intensity of anaphylactic reactions after injections according to the World Allergy Organization (WAO) grading system,
    • the use of anti-symptomatic co-therapy
    • the change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase,
    • the change of vital signs,
    • the change of PEF from patients, measured before, during and after treatment,
    • an assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale.

    Exploratory immunological parameters will be evaluated at Screening (S1) and Final Visit (FV):
    • Specific IgG4 for Phleum pratense.
    Das Ziel dieser Studie ist es Informationen zur Sicherheit und Verträglichkeit einer intrasaisonalen Aufdosierung mit Allergovit® 6-Gräser im Vergleich mit einer Standard-Aufdosierung zu erhalten.
    Um dieses Ziel zu erreichen werden die folgenden Sicherheitsparameter beurteilt:
    • die Inzidenz, Art und Intensivität von unerwünschten Ereignissen (AE) und schwerwiegenden unerwünschten Ereignissen (SAE) gemäß MedDRA „primary system organ class“ (SOC) und „preferred term“
    • die Inzidenz, Art und Intensivität von unerwünschten Ereignissen (AE) die vom Prüfarzt der Studienmedikation zugeordnet werden gemäß MedDRA „primary system organ class“ (SOC) und „preferred term“
    • die Inzidenz, Art und Intensivität von lokalen AEs die vom Prüfarzt der Studienmedikation zugeordnet werden gemäß MedDRA „primary system organ class“ (SOC) und „preferred term
    • die Inzidenz und Intensivität von anaphylaktischen Reaktionen nach Injektionen gemäß des World Allergy Organization (WAO) grading system
    • die Verwendung von anti-symptomatischer Begleittherapie
    • die Änderung der Labor Werte (Hämatology, Klinische Chemie und Urinanalyse) gemessen vor und nach der Behandlungsphase
    • die Änderung der Vitalfunktionen
    • die Änderung der Lungen-Spitzenflussmessung (PEF) bei den Patienten, gemessen vor und nach der Behandlungsphase
    • eine Bewertung der Gesamtverträglichkeit durch Prüfarzt und Patient unter Verwendung einer 5-Punkte-Skala

    Als immunologischer Forschungsparameter wird beim Einschluss- (S1) und Abschlussbesuch (FV) untersucht:
    • Spezifisches IgG4 für Phleum pratense.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After database lock, approximatly April 2017.
    Nach Datenbankschluss, voraussichtlich im April 2017.
    E.5.2Secondary end point(s)
    Not applicable.
    Nicht zutreffend.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Nicht zutreffend.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    An assessment of the overall tolerability will be done by the investigator and patient using the 5-point Likert scale.
    Verträglichkeit anhand der Likert Skala beurteilt von Patient und Prüfarzt.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    Same medical product, Allergovit® 6-grasses in both arms with therapy different starting points
    E.8.2.4Number of treatment arms in the trial2
    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 concerned25
    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 No
    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
    Database lock in order to permit data cleaning after last patient last visit with the trial sites.
    Datenbankschluß, um nach der letzten Patientenvisite das data cleaning abgeschlossen zu haben.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    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: 240
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    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)
    After the last individual trial specific visit, each patient will be further treated at the investigator’s discretion. The sponsor will not provide any further treatment after the end of study participation.
    Am Studienende muß der Prüfarzt über die weitere individuelle Behandlung eines jeden Patienten entscheiden. Der Sponsor wird nach Studieneteilnahme keine weitere Behandlung zur Verfügung stellen.
    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 Decision2015-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-11
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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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