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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-000754-19
    Sponsor's Protocol Code Number:AL1602av
    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:2017-05-11
    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 number2017-000754-19
    A.3Full title of the trial
    A multicentre, randomized, open label clinical trial for safety evaluation of an accelerated high dose escalation schedule with one strength for an allergen immunotherapy with an aluminium hydroxide adsorbed allergoid preparation of 6-Grasses in patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without 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 centers to investigate the safety of an accelerated high dose escalation schedule for an immune therapy in patients with hayfever with or without asthma.
    A.3.2Name or abbreviated title of the trial where available
    ONSeT
    A.4.1Sponsor's protocol code numberAL1602av
    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 pointDr. Kirsten Plückhahn
    B.5.3 Address:
    B.5.3.1Street AddressHermann-Körner-Straße 52
    B.5.3.2Town/ cityReinbek
    B.5.3.3Post code21465
    B.5.3.4CountryGermany
    B.5.4Telephone number00494072765470
    B.5.5Fax number00494072765600
    B.5.6E-mailkirsten.plueckhahn@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® 6-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® 6-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® 6-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 unit(s)
    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 asthma
    E.1.1.1Medical condition in easily understood language
    Patients suffering from hay fever with or without asthma
    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 20.1
    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 20.0
    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 20.0
    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 20.0
    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 20.0
    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 II trial is to evaluate the safety and tolerability of an accelerated high dose escalation schedule with one strength for allergen immunotherapy with Allergovit® 6-Grasses compared to the standard escalation schedule with two strengths. Adult patients with rhinitis or rhinoconjunctivitis caused by grass pollen, with or without allergic asthma on a well controlled level, will be enrolled.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent given from patient 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 between 18 to ≤ 65 years
    4. IgE-mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by grass pollen documented by:
    • Skin prick test (SPT):
    • wheal for grass pollen ≥ 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 pollen
    5. At least 1 month symptoms of allergic rhinitis or rhinoconjunctivitis in May to August triggered by grass pollen exposure over the last two seasons.
    6. In case of bronchial asthma at entry: confirmed diagnosis of asthma according to GINA guideline (GINA, 2017)
    7. In case of a diagnosed asthma: asthma symptoms classified as being “well controlled” according to GINA guideline (GINA, 2017)
    8. Previous treatment with anti-allergic treatment for at least 2 seasons prior to enrolment
    E.4Principal exclusion criteria
    General criteria:
    1. Patient is unable to understand and comply with the requirements of the trial, as judged by the investigator
    2. Currently participating in any other clinical trial or participating in any other clinical trial within 30 days prior informed consent for 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
    6. Any relationship of dependence with the sponsor or with the investigator
    7. Previous randomization to treatment in the present trial
    8. Mentally disabled
    9. 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 post-menopausal):
    10. Positive pregnancy test or pregnant
    11. 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)
    12. Wish to breast feed or breast feeding
    13. Wish to become pregnant during the course of the trial
    Immunotherapy criteria:
    14. History of a confirmed anaphylaxis after an AIT injection
    15. AIT with grass pollen within the last 5 years
    16. Current treatment with any kind of immunotherapy
    17. AIT with unknown allergen within the last 5 years
    Diseases and health status:
    18. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
    19. Forced expiratory volume in 1 second (FEV1) < 70 % of predicted normal values (ECSC) under adequate asthma treatment according to GINA guidelines (GINA, 2017)
    20. Uncontrolled or partly controlled asthma according to GINA guidelines (GINA, 2017)
    21. Acute asthma attack within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency visit
    22. Rhinoconjunctival atopic symptoms for 20 years or longer
    23. Severe acute or chronic diseases (e.g. chronic urticaria, mastocytose, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)
    24. Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease, multiple sclerosis)
    25. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
    26. Recurrent seizures (e.g. febrile convulsion, untreated epilepsy)
    27. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
    28. 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). For assessment the normal ranges of the central laboratory should be applied.
    Medications:
    29. Use of beta-blockers (locally or systemically), ACE inhibitors
    30. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension)
    31. Completion or ongoing treatment with anti-IgE-antibody
    32. Completion or ongoing long-term treatment with tranquilizer or other psychoactive drugs
    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 accelerated dose escalation schedule with one strength for allergen immunotherapy with Allergovit® 6-Grasses.
    The following descriptive safety variables will be considered:
    • Number, incidence, time of onset, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term
    • Number, incidence, time of onset, type and intensity of AEs and serious adverse events assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term
    • Incidence and intensity of allergic systemic reactions after injections according to the World Allergy Organization (WAO) grading system (see Section 18.4)
    • Number of patients reaching the maintenance dose without dose adjustment due to adverse events
    • Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase
    • Change of vital signs and lung function measured before and after the treatment phase
    • Assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After database lock
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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
    Assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale
    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 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 IMP in both arms but different number of injections, standard versus accelerated
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Poland
    Russian Federation
    Spain
    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
    The end of the trial is defined as the database lock in order to permit the data cleaning procedure after the last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 70
    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)
    At the end of the trial the investigator has to decide on the further individual treatment of each patient. The sponsor will not provide any further treatment after the end of trial participation.
    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 Decision2017-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
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