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    Summary
    EudraCT Number:2011-004185-14
    Sponsor's Protocol Code Number:CDPG103ADE01
    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:2011-10-05
    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 number2011-004185-14
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy
    and safety of intraseasonal specific short-term immunotherapy with depigmented glutaraldehyde polymerized birch pollen allergenic extract (Depiquick® Birch) in patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate the efficacy and safety of an antiallergic therapy, which will be administered against rhinitis and/or rhinoconjunctivitis with or without intermittent asthma as allergic reaction to birch pollen. The study drug Depiquick® Birch used for this immunotherapy is a chemically modified extract of birch pollen.
    A.4.1Sponsor's protocol code numberCDPG103ADE01
    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 SponsorNovartis Pharma GmbH
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+491802232300
    B.5.5Fax number+4991127312160
    B.5.6E-mailinfoservice.novartis@novartis.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 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 nameDepiquick® Birch
    D.3.2Product code Depiquick® Birch 1000 DPP/mL
    D.3.4Pharmaceutical form Solution 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.3.9.2Current sponsor codeDepiquick® Birke
    D.3.9.3Other descriptive nameBirch allergen extract
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma.
    E.1.1.1Medical condition in easily understood language
    Hay fever with or without asthma due to birch pollen.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10039776
    E.1.2Term Seasonal allergic rhinitis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of Depiquick® Birch (1,000 DPP/mL) over Depiquick®-matching placebo (0 DPP/mL) with regard to efficacy of intraseasonal SIT as assessed by the combined symptom and medication score (SMS) for rhinitis/rhinoconjunctivitis on the basis of the primary tree pollen exposition time.
    E.2.2Secondary objectives of the trial
    - SMS for rhinitis/rhinoconjunctivitis on the basis of all days with a certain median symptom score
    - Onset of action of intraseasonal specific short-term immunotherapy
    - Symptom score on the basis of the primary tree pollen exposition time
    - Symptom score on the basis of all days with a certain median symptom score
    - Medication score on the basis of the primary tree pollen exposition time
    - Medication score on the basis of all days with a certain median symptom score
    - Medication score by patients’ assessment
    - Health-related quality of life
    - Percentage of well days
    - Global evaluation of efficacy and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. For adolescents (≥ 12 and < 18 years of age), a legal representative will sign the informed study consent.
    2. Patients must be ≥ 12 and ≤ 70 years of age at visit 1
    3. If visit 1 is conducted before the pollen season (no allergic symptoms): Patients must have a perception of disease activity during previous tree pollen seasons of at least 30 mm on a 100 mm visual analogue scale (VAS)
    4. Patients must be capable to complete the eDiary on a daily basis from visit 2 to visit 8 (at the discretion of the investigator)
    5. Patients must experience significant allergic symptoms (defined by symptom score ≥ 2) at
    visit 2
    6. Patients must complain about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years with or without intermittent asthma symptoms, caused by clinical sensitization against tree pollen
    7. IgE-mediated sensitization has to be verified by:
    - suggestive medical history, and
    - specific IgE against birch pollen (CAP-RAST ≥ 2), and
    - a positive SPT to birch pollen (the SPT is considered positive if it results in a wheal
    diameter of at least 3 mm),

    Special criteria for patients with co-allergies:
    For all patients with co-allergies as a result of sensitization against grass and/or weed pollen and/or perennial allergens (e.g. house dust mites, animal dander), all of the following inclusion criteria must be fulfilled:
    8. Patients have to be asymptomatic against co-allergens such as grass or weed pollen, house dust mites, cat and dog
    9. Specific CAP-RAST co-allergen < birch, as specified below:
    - Grass and house dust mites: specific CAP-RAST of < 2 with a difference to birch of ≥ 2 and a negative SPT
    - Cats and dogs: exposed to animal: specific CAP-RAST animal < birch with a difference to birch of ≥ 2 and an SPT wheal diameter co-allergen < birch; not exposed to animal: CAP-RAST animal < birch
    - All other co-allergens: difference in specific CAP RAST co-allergen to birch of ≥ 2 and an SPT wheal diameter co-allergen < birch
    10. Patients not fulfilling inclusion criterion number 9 are eligible for the study if a negative provocation test(s) for the co-allergen(s) not fulfilling the co-allergy criteria is(are) available. The provocation test(s) must not be older than 12 months at visit 1.
    E.4Principal exclusion criteria
    1. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens (e.g. house dust mites). Patients are not allowed to enter the study:
    - with typical symptoms against co-allergens such as grass/weed pollen, house dust mites, cat and dog
    - with CAP-RAST co allergen ≥ birch (not applicable if negative provocation test for
    co-allergen not older than 12 months is available)
    2. FEV1 or PEF value ≤ 80% of the predicted normal value (for PEF: highest result of 3 measurements)
    3. Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines
    4. Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis and nasal polyposis
    5. Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis)
    6. Diseases of the immune system including autoimmune and immune deficiencies
    7. Any disease, which prohibits the use of adrenaline (e.g. hyperthyroidism)
    8. Severe uncontrolled diseases that could increase the risk for the patients participating in the study, which include but are not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or hematological disorders
    9. Any malignant disease during the previous 5 years
    10. Any significant abnormal laboratory parameter or alteration in the vital signs that could increase the risk for the study patient
    11. Alcohol, drug, or medication abuse within the past year
    12. Severe psychiatric, psychological, or neurological disorders
    13. Use of immunotherapy against birch or tree pollen within the last 5 years
    14. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer
    15. Topical and systemic treatment with β-blockers
    16. Treatment with substances interfering with the immune system within 1 week prior to Visit 2
    17. Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1
    18. Use of systemic corticosteroids within 4 weeks prior to Visit 1
    19. Immunization with vaccines within 7 days prior to Visit 2
    20. Any condition which could interfere with the study objectives
    21. Patients with hypersensitivity to excipients (see Section 6.2) of the investigational medicinal product
    22. Patients expected to be non-compliant and/or not co-operative
    23. Patients who have already participated in this study
    24. Patients who are employees of the institution, or 1st grade relatives, or partners of the investigator
    25. Women
    ■ who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine
    pregnancy test.
    ■ who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (urine) for all women and for girlsentering menarche is required with sufficient lead time before inclusion
    26. Persons who are jurisdictionally or governmentally institutionalized
    E.5 End points
    E.5.1Primary end point(s)
    - combined symptom and rescue medication score (SMS) over the primary exposition time
    E.5.1.1Timepoint(s) of evaluation of this end point
    - daily during primary exposition time
    E.5.2Secondary end point(s)
    - combined symptom and rescue medication score (SMS) over the secondary exposition time
    - quality of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    - daily during secondary exposition time
    - visit 2, 4, 6, 7
    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 No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned40
    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 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 months8
    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 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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)
    After patients have ended the participation in the trial, including a follow-up period, patients are treated by their general practitioner or medical specialist.
    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 Decision2012-02-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
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