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    Summary
    EudraCT Number:2022-001587-97
    Sponsor's Protocol Code Number:SC-322A
    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:2022-12-27
    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 number2022-001587-97
    A.3Full title of the trial
    Phase II-III study to assess the efficacy and safety of subcutaneous cluster-immunotherapy in patients suffering from birch pollen allergy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy and safety of subcutaneous immunotherapy in patients suffering from birch pollen-related allergy
    A.3.2Name or abbreviated title of the trial where available
    CLUSTOID Birke phase II-III study
    A.4.1Sponsor's protocol code numberSC-322A
    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 pointMedical Manager
    B.5.3 Address:
    B.5.3.1Street AddressMeessen 20
    B.5.3.2Town/ cityOststeinbek
    B.5.3.3Post code22113
    B.5.3.4CountryGermany
    B.5.4Telephone number+49408972520
    B.5.5Fax number+494089725223
    B.5.6E-mailcta@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 Yes
    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 Birke
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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
    Patients with birch pollen-related allergic rhinitis/rhinoconjunctivitis and with well-controlled mild-to-moderate or without asthma
    E.1.1.1Medical condition in easily understood language
    Patients with birch pollen-related hay fever and mild-to-moderate asthma or without asthma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10039085
    E.1.2Term Rhinitis allergic
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10010744
    E.1.2Term Conjunctivitis allergic
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose and main objective of this trial is to establish the most effective and best-tolerated dose with CLUSTOID Birke in terms of benefit-risk balance and CSMS (Combined Symptom and Medication Score)
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to support the evaluation of the efficacy of each dose treatment with CLUSTOID Birke compared to placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory endpoints:
    - To assess the immunogenicity of each concentration of CLUSTOID® Betula verrucosa compared to placebo by changes in the serum specific immunoglobulin levels (specific IgG4 against Betula verrucosa) from beginning to end of treatment.
    - Investigator-rated tolerability of the treatment (0-to-10 scale).
    - Patient-rated satisfaction with treatment (0-to-10 scale).
    - Plasma and urine levels of aluminum (Pharmacokinetics). To be performed in a subgroup of patients at V0 (pre-treatment), V3 (after first and before second maintenance dose) and FV (post-treatment).
    E.3Principal inclusion criteria
    Criteria for Inclusion

    • Patients who signed and dated the informed consent form obtained prior to any study-specific examination
    • Female or male patients between 18 and 65 years of age at the time of signing the informed consent form
    • Patients with moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to birch pollen for at least two years according to the Allergic Rhinitis and its impact on Asthma (ARIA) guideline.
    • Patients with well-controlled mild-to-moderate or without asthma defined in GINA guideline (Global Initiative for Asthma, 2022).
    • Forced expiratory volume (FEV1) in one second > 80 % of predicted normal value (only for asthmatic patients)
    • Sensitization to Betula verrucosa pollen, verified by:
     positive skin prick test (wheal diameter ≥ 3 mm and negative control < 2 mm and positive (histamine) control ≥ 3 mm) and
     serum allergen-specific IgE to Betula verrucosa ≥ 0.7 kU/L (CAP EAST class ≥ 2) and
     a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 2 (0-3 scale) based on the most severe days during one of the two BPS preceding enrolment and
     positive response to nasal provocation with Betula verrucosa pollen allergen extract (at least at the third concentration step)
    • Assumed compliance and ability of the patient to understand the patient’s electronic diary and to follow the instructions of the study staff
    • Compliance and ability of the patient to complete an electronic diary for self-evaluation of the symptoms and rescue medication
    • Safety laboratory results within the normal range or considered to be not clinically significant in any other case
    E.4Principal exclusion criteria
    Criteria for Exclusion

    • Previous immunotherapy with birch pollen allergen extracts according to the homologous group of tree pollen of the “Birch group” / “Fagales group”, as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831), within the last 5 years
    • Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen (with exception of alder, hazel and hornbeam), which interfere with the conduct of the study (e. g. with the tNPT), especially if the result in SPT for this allergen is higher than that for Betula verrucosa
    • Patients with co-sensitizations to any pollen or mould with overlapping seasons but which are not cross-reactive with Betula verrucosa and with specific IgE levels ≥ class 2 CAP/PHADIA (unless the relevance can be excluded by component resolved diagnosis)
    • Simultaneous participation in other clinical trials
    • Simultaneous specific immunotherapy with other allergens
    • Participation in a trial in the last three months before enrolment
    • Contraindications for SCIT (Pfaar et al., 2014b; Pitsios et al., 2015)
    • Contraindications for SPT
    • Contraindications for NPT
    • Serious systemic reactions to allergen-specific immunotherapy in the past
    • Hypersensitivity to excipients of the IMP
    • Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
    • Severe, or partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2022)
    • Asthmatic patients with FEV1 ≤ 80 % of predicted normal value at screening
    • Chronic or severe acute diseases of nose or eyes
    • Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)
    • Therapy with immunoglobulins
    • Completed or ongoing treatment with anti-IgE-antibody
    • Diseases of the immune system including autoimmune and immune deficiencies (with exception to well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
    • Severe acute or chronic inflammatory or infectious diseases
    • Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function
    • Malignancy within the previous 5 years
    • Active chronic urticaria
    • Active severe atopic eczema
    • Alcohol, drug, or medication abuse within the past year and/or during the study
    • 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
    • Use of non-allowed medication
    • Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma)
    • Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizer or psychoactive drugs (including tricyclic anti-depressants)
    • Relationship or dependence with the sponsor and/or investigator
    • Legal incapacity
    • Patients who are jurisdictional or governmentally institutionalized
    • Risk of non-compliance by the patient with the study procedures
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS during Peak Birch Pollen Period (PBPP) of each active treatment group compared to placebo treatment group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10.07.2023 to 20.08.2025
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    - Absolute and relative differences in mean CSMS during Birch Pollen Season (BPS) between active and placebo treatment groups.
    - Absolute and relative differences in mean dSS during PBPP and BPS.
    - Absolute and relative differences in mean dMS during PBPP and BPS.
    - Global Rhinoconjunctivitis Discomfort with a 10-point Visual Analogue Scale (VAS).
    - Change in Rhinoconjunctivitis quality of life questionnaire (RQLQ) between active and placebo treatment groups comparing basal and post-treatment scoring.
    - Well and severe days: A well day is defined as a day without administration of any rescue medication (dMS = 0) and with dSS < 0.34 (range 0-3). A severe day is defined (acc. to Pfaar et al. 2014a) as a day with a single score = 3 in any of the six symptoms. Percentages of well and severe days will be calculated for each subject as the number of well or severe days in the PBPP and BPS in relation to the number of days comprising both periods.
    - Symptom-free days are defined as the days with absence of symptoms (dSS = 0) and without administration of any rescue medication (dMS = 0), expressed as percentage of days during the PBPP and BPS.
    - tNPT titrated Nasal Provocation Test: To assess the efficacy of each dose of CLUSTOID® Betula verrucosa compared to placebo. Defined as percentage of patients with an increased dosing step and the change in number of dosing steps 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 four treatment groups. This is based on the change of the response to nasal provocation (tNPT) with incremental concentrations of an allergen extract of Betula verrucosa from baseline to end of treatment.

    Secondary safety endpoint:
    - To analyse the safety and tolerability of each dose of CLUSTOID® Betula verrucosa compared to placebo by Treatment-Emergent Adverse Drug Reactions (TEADR) and patients affected with TEADRs in each group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10.07.2023 to 20.08.2025
    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 Yes
    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) 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 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 concerned4
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Kazakhstan
    Turkey
    Ukraine
    Serbia
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days10
    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: 560
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 560
    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 Decision2023-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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