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    EudraCT Number:2021-002252-36
    Sponsor's Protocol Code Number:T502-SIT-045
    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:2021-06-18
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-002252-36
    A.3Full title of the trial
    A prospective, randomized, double-blind placebo-controlled multicentre study with 10 000 mTU/mL mannan-conjugated birch pollen allergoids administered subcutaneously to patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective, randomized, double-blind placebo-controlled multicentre study with 10 000 mTU/mL mannan-conjugated birch pollen allergoids administered subcutaneously to patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
    A.4.1Sponsor's protocol code numberT502-SIT-045
    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 SponsorInmunotek S.L.
    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 supportInmunotek S.L.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinCompetence Cologne GmbH
    B.5.2Functional name of contact pointContract Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Heuss-Ring 14
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50668
    B.5.4Telephone number+492217161330
    B.5.5Fax number+4922171613329
    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 nameT502 10 000 mTU/mL
    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 INNT502
    D.3.9.1CAS number 8000045-25-2
    D.3.9.2Current sponsor codeT502
    D.3.9.3Other descriptive nameALLERGENS, POLLEN & PLANT EXTRACT
    D.3.9.4EV Substance CodeSUB12787MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Treatment of birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
    Behandlung der durch Birkenpollen ausgelösten allergischen Rhinitis
    oder Konjunktivitis.
    E.1.1.1Medical condition in easily understood language
    Treatment of birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
    Behandlung der durch Birkenpollen ausgelösten allergischen Rhinitis
    oder Konjunktivitis.
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to assess the clinical impact of T502 treatment administered subcutaneously to patients with birch pollen-induced allergic rhinoconjunctivitis.
    - The effect will be assessed by comparing the symptoms and the medication need in actively treated and placebo patients during the peak birch pollen season.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To assess the safety and clinical tolerability of T502 treatment
    • To assess the impact of T502 on the immunological status of the patients in comparison to placebo
    • To assess the clinical impact of T502 in comparison to placebo with regard to health-related quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria in order to participate in this study:
    • Signed and dated Informed Consent Form by a legally competent patient,
    • Female, male or diverse patients aged 18 to 64 years,
    • Being in good physical and mental health,
    • Confirmed normal renal and liver function, including non-clinically significant deviations outside the reference ranges (< grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit*),
    • For females: non-pregnant, non-lactating with adequate contraception as defined in chapter VI.1, or females unable to bear children (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]),
    • Having the diagnosis of birch pollen allergy based on all the following criteria:
    - A medical history of moderate to severe allergic rhinoconjunctivitis for birch pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA),
    - A positive skin prick test (SPT - wheal diameter ≥3 mm) to birch pollen allergens, positive control (histamine) wheal ≥3 mm, negative control (NaCl) wheal <2 mm,
    - Specific IgE against birch pollen allergens (minimum CAP class 3 or higher, ≥3.5 kU/L),
    • Being treated with anti-allergic medication for at least 2 seasons prior to enrolment,
    • For asthmatic patients: confirmed diagnosis of controlled asthma during the treatment period according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2021),
    • FEV1 ≥80% of the patient’s reference value or Peak Expiratory Flow (PEF) ≥80% of the patients´ individual optimal value (for asthmatic patients only).
    E.4Principal exclusion criteria
    • Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion,
    • Previous immunotherapy with birch pollen allergens within the last 5 years,
    • Ongoing immunotherapy with birch pollen allergens or any other allergens,
    • Patients with acute allergic rhinoconjunctivitis due to other environmental allergens during the study period,
    • Patients with a sensitization to other environmental allergens (e.g., house dust mites, cat dander, dog dander) and whose CAP class of the respective allergen specific IgE is equal or higher than for birch pollen specific IgE,
    • Being in any relationship or dependence with the Sponsor, CRO and/or Investigator,
    • Inability to understand instructions/study documents,
    • Patients who do not have access to a smartphone/tablet (iOS or Android)#,
    • History of severe systemic reactions and/or anaphylaxis, including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc.,
    • Patients who have a suspected or symptoms of a SARS-COV-2 infection, who have had contact with a confirmed case of COVID-19.
    • History of hypersensitivity to the excipients of the investigational product or placebo,
    • Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2021) during the treatment period,
    • Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) <80% of the patient’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the patients’ individual optimal value,
    • History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening,
    • History of significant renal disease or chronic hepatic disease,
    • Malignant active disease (ongoing or within the five past years),
    • Severe autoimmune disease,
    • Immune defects including immunosuppression, immunopathies,
    • Vaccination during the entire treatment period, except flu and SARS-CoV-2 vaccinations – see Chapter “Non-allowed drugs and procedures”,
    • Use of systemic immunosuppressive medications (e.g., methotrexate or cyclosporine A) or blood transfusion one month before screening,
    • General inflammatory, severe acute or chronic inflammatory diseases,
    • Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
    • Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g., doxepin, amitriptyline, desipramine, imipramine, etc.),
    • Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents,
    • Intake of beta-blockers/ACE inhibitor medication (angiotensin-converting enzyme inhibitor),
    • Active tuberculosis,
    • Having any contraindication for the use of adrenaline (including hyperthyroidism),
    • Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus,
    • Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method,
    • Administration of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within a defined time period preceding the trial (screening visit), as defined in the protocol, exception made for routine (previously prescribed) control medication for asthmatic patients,
    • Clinically relevant laboratory values, i.e., grade ≥2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit*,
    • Patients for who the Investigator believes will not comply with the study protocol (patients with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol).
    E.5 End points
    E.5.1Primary end point(s)
    The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2022 between the placebo and the active treatment group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The Combines Symptom and Medication Score (CSMS) will be evaluated over the peak birch pollen season 2022.
    E.5.2Secondary end point(s)
    Safety and clinical tolerability assessment of T502 treatment will be assessed by:
    - Solicited adverse events
    • Local reactions at the injection site (swelling and redness)
    • Systemic allergic reactions after administration of the investigational product.
    - Unsolicited adverse events and serious adverse events
    - Physical examinations and vital signs
    - Laboratory investigations (blood count, renal and liver function-related parameters)
    - Pulmonary function testing for asthmatic patients
    - Use of rescue medication during the treatment phase

    Clinical immunogenicity endpoints will include:
    - Production of birch pollen-specific immunoglobulins IgE, IgG and IgG4
    - Production of Blocking Antibodies (FAB assay, assessment in some centres in Germany)

    Clinical impact endpoints will include:
    - The Combined Symptom and Medication Score (CSMS) over the entire birch pollen season 2022
    - The mean daily Symptom Score (dSS) over the birch peak pollen season and the entire birch pollen season
    - The mean daily Medication Score (dMS) over the birch peak pollen season and the entire birch pollen season
    - Differences between placebo- and actively treated patients in health-related Quality of Life during the birch pollen season (V7, V8)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Solicited AEs will be evaluated between V2 and V7, unsolicited AEs and
    SAEs between V1 and V9.
    Physical examinations and vital signs will be evaluated between V1 - V9.
    Safety laboratory investigations will be done at V1 and V7.
    The use of rescue medication during the treatment phase will be evaluated between V2 and V6.
    Immunogenicity endpoints will be measured at V 1 and V7.
    CSMS will be evaluated over the entire pollen season.
    RQLQ will be evaluated at V7 and V8.
    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 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. 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 concerned30
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 360
    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 state360
    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)
    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 Decision2021-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-13
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