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    Summary
    EudraCT Number:2010-022083-12
    Sponsor's Protocol Code Number:SC-11A
    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:2011-07-28
    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 number2010-022083-12
    A.3Full title of the trial
    Evaluation of tolerability and efficacy of subcutaneous cluster-immunotherapy in patients with allergic rhinitis / rhino-conjunctivitis due to grass pollen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of tolerability and efficacy of subcutaneous cluster-immunotherapy in patients with allergic rhinitis / rhino-conjunctivitis due to grass pollen
    A.3.2Name or abbreviated title of the trial where available
    CLUSTOID® Tolerability and efficacy
    A.4.1Sponsor's protocol code numberSC-11A
    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 SponsorROXALL Medizin 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 supportROXALL Medizin GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationROXALL Medizin GmbH
    B.5.2Functional name of contact pointROXALL Medizin GmbH
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Petersen-Str. 4
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20535
    B.5.3.4CountryGermany
    B.5.4Telephone number0049408972520
    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 nameCLUSTOID Wiesenlieschgras
    D.3.2Product code CLUSTOID Wiesenlieschgras
    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 INNCLUSTOID Wiesenlieschgras
    D.3.9.3Other descriptive nameModified allergen extract from pollen of Phleum pratense
    D.3.9.4EV Substance CodeSUB12780MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2000 to 50000
    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
    Allergic rhinitis / rhino-conjunctivitis
    E.1.1.1Medical condition in easily understood language
    Allergic rhinitis / rhino-conjunctivitis
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: to assess the efficacy of four different
    concentrations for subcutaneous immunotherapy with cluster-allergoid
    CLUSTOID® Wiesenlieschgras by means of the threshold concentration
    that is needed to provoke an allergic response after titrated nasal
    provocation with increasing concentrations of an allergen extract of
    Phleum pratense.
    E.2.2Secondary objectives of the trial
    Secondary objective: to assess the tolerability and safety of the
    treatment using four different concentrations for subcutaneous
    immunotherapy with cluster-allergoid CLUSTOID® Wiesenlieschgras.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Signed and dated patient's informed consent obtained prior to any study specific examination
    •Female or male patients aged 18–75 with allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal controlled allergic asthma [The Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2010, http://www.ginasthma.org]
    •Clinically relevant allergy to grass pollen for at least 2 consecutive years
    •The sensitization to other aero-allergens and/or to mites, cats and dogs, has to be considered as not clinically relevant or that the allergic symptoms do not interfere with the study
    •Positive clinical history of grass pollen, verified by:
    - positive screening skin prick test (SPT) against timothy pollen (wheal diameter ≥3 mm) and
    - a clear negative result to the negative control (max. wheal diameter <2 mm) and
    - a clear positive result to the histamine control (wheal diameter ≥3 mm) and
    - presence of specific IgE against timothy pollen (positive CAP EAST class II and above) and
    - a positive reaction after nasal provocation with a timothy allergen concentration of <=1,666 BU/mL and
    - anti-allergic or anti-asthmatic treatment during the previous grass pollen season
    •An RRTSS during the previous pollen season of greater than or equal to nine
    •Compliance and ability of the patient to follow the instructions of the study stuff for the nasal provocation test (NPT)
    •Safety laboratory results within the normal range or out of normal range but considered as not clinically significant
    E.4Principal exclusion criteria
    •Previous immunotherapy with grass pollen extracts from the homologous group of grass and cereal pollen according to Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831/2007) within the last 5 years
    •Predominant perennial allergic rhinitis
    •Predominant perennial allergic asthma
    •Simultaneous participation in other clinical trials
    •Other reasons contra-indicating an inclusion into the trial according to the investigator's judgment (e.g. expected poor compliance)
    •Active tuberculosis
    •Patients with hypersensitivity to excipients of the investigational medicinal product
    •Any significant abnormal laboratory parameters or alteration in the vital signs that could increase the risk for the study patient
    •Diseases of the immune system including autoimmune and immune deficiencies
    •Immunosuppressive therapy
    •Severe chronic inflammatory diseases
    •Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis
    •Malignancy during the previous 5 years
    •Alcohol, drug, or medication abuse within the past year
    •Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection
    •Irreversible secondary disorders at the target organs (e.g. emphysema, bronchoectasis)
    •Systemic and local (eyedrops) treatment with beta-blockers
    •Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1
    •Use of systemic corticosteroids within 3 months prior to Visit 1
    •Immunization with vaccines within 7 days prior to Visit 1
    •Patients treated with other contra-indicated drugs (cf. section 11.2)
    •Partly controlled or uncontrolled asthma according to the Global Initiative for Asthma (GINA) Guideline, e.g. PEF or FEV1-value <80% of the predicted normal values calcula-ted by regression formulas (ERS EGKS 1993) according to: www.vitalograph.de/spirometry_normal_values_guidelines.php
    •Inflammation and infect of the target organs (e.g. nose, eyes, lung)
    •Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism)
    •Completed or ongoing long-term treatment with tranquilizer or psycho active drugs
    •Completed or ongoing treatment with anti-IgE-antibody
    •Suspected inability to understand instructions/ study documents
    •Severe psychiatric, psychological, or neurological disorders
    •Patients being in any relationship or dependence with the Sponsor and/or investigator
    •Nursing (lactating) women or a positive pregnancy test at Visit 1
    •Patients who are not contractually capable
    •Persons who are jurisdictional or governmentally institutionalized
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to assess the efficacy of four different
    concentrations for subcutaneous immunotherapy with cluster-allergoid CLUSTOID® Wiesenlieschgras by means of determining the threshold
    concentration that is needed to provoke a positive allergic response after nasal provocation with escalating concentrations of an allergen extract
    of Phleum pratense.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month after start of the study.
    E.5.2Secondary end point(s)
    The secondary objective is to assess the tolerability and safety of four different concentrations for subcutaneous immunotherapy with cluster allergoid
    CLUSTOID® Wiesenlieschgras.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 month after start of the study.
    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 Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different concentrations of the medicinal product
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned 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: 87
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state92
    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)
    none
    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 Decision2014-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
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