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    Summary
    EudraCT Number:2011-002317-10
    Sponsor's Protocol Code Number:SC-31A
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-11
    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 number2011-002317-10
    A.3Full title of the trial
    Phase II study to assess the tolerability, safety and efficacy of subcutaneous cluster-immunotherapy in patients suffering from house dust mite allergy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study to assess the tolerability, safety and efficacy of subcutaneous cluster-immunotherapy in patients suffering from house dust mite allergy
    A.3.2Name or abbreviated title of the trial where available
    Tolerability and efficacy of CLUSTOID mite extract
    A.4.1Sponsor's protocol code numberSC-31A
    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
    B.5.5Fax number00494089725223
    B.5.6E-mailct@roxall.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 nameCLUSTOID D. pteronyssinus
    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 D. pteronyssinus
    D.3.9.3Other descriptive nameModified allergen extract of Dermatophagoides pteronyssinus
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension 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 / 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 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 10020419
    E.1.2Term House dust mite allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10034382
    E.1.2Term Perennial 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
    To assess the efficacy of four different doses of CLUSTOID® D. pteronyssinus compared to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five trial groups.
    E.2.2Secondary objectives of the trial
    To assess the tolerability and safety of four different doses of CLUSTOID® D. pteronyssinus compared to placebo by occurrence of treatment-related adverse events.
    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 18-65 at the time of informed consent
    • History of allergic rhinitis / rhinoconjunctivitis due to house dust mites with or without well controlled asthma according to GINA guideline (Global Initiative for Asthma, 2017) for at least 1 year
    • Sensitization to Dermatophagoides pteronyssinus, verified by:
    - positive skin prick test (wheal diameter ≥ 3 mm and negative control < 2 mm and positive (histamine) control ≥ 3 mm) and
    - Serum specific IgE ≥ 0.7 kU/L (CAP EAST class ≥ 2) and
    - positive response to nasal provocation with D. pteronyssinus allergen extract
    • Assumed compliance and ability of the patient to follow the instructions of the study staff
    E.4Principal exclusion criteria
    • Previous immunotherapy with allergen extract of house dust mites according to the homologous group of the Dermatophagoides genus in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831) within the last 5 years
    • Simultaneous participation in other clinical trials
    • Simultaneous specific immunotherapy with other allergens
    • Usual contraindications for SCIT
    • History of anaphylaxis
    • Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
    • Irreversible secondary disorders of the target organs (e. g. emphysema, bronchoectasis)
    • Completed or ongoing treatment with anti-IgE-antibody
    • Diseases of the immune system including autoimmune and immune deficiencies
    • Severe acute or chronic inflammatory or infectious diseases
    • Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening
    • Systemic and local (eye drops) treatment with beta-blockers
    • Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017).
    • Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma)
    • Relationship or dependence with the sponsor and/or investigator
    E.5 End points
    E.5.1Primary end point(s)
    To assess the efficacy of four different doses of CLUSTOID® D. pteronyssinus compared to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five trial groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 months after start of the study
    E.5.2Secondary end point(s)
    To assess the tolerability and safety of four different doses of CLUSTOID® D. pteronyssinus compared to placebo by occurrence of treatment-related adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 months 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 Yes
    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 trial5
    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 concerned19
    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 years1
    E.8.9.1In the Member State concerned months10
    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: 160
    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 state165
    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 Decision2018-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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