Treatment of birch pollen-induced allergic rhinitis or rhinoconjunctivitis MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Sponsors
Inmunotek S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed and dated Informed Consent Form by a legally competent patient, • Participation in the T502-SIT-020 trial, • Being in good physical and mental health, • Confirmed normal renal and liver function, including non-clinically significant deviations outside the reference ranges (=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: • Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion, • No participation in the T502-SIT-020 study • Ongoing immunotherapy with birch pollen allergens or any other allergens, • 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., • 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 2014) 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, • Patients who have suspicion or symptoms of a SARS-COV-2 infection, who have had contact with a confirmed case of COVID-19, or returned from a COVID-19 risk region in the 2 weeks prior to the screening visit. • Patients with acute allergic rhinoconjunctivitis due to other environmental allergens during the study period, • 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 treatment periods DEC 2020 - MAR 2021 and DEC 2021 - MAR 2022 except Influenza and SARS-CoV-2 vaccinations – see Chapter XII.2 ‘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 which is defined in chapter VI.1 ‘Inclusion Criteria’, • Administration of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within the 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 Vacci
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to assess the clinical impact of the subcutaneous administration of Mannan conjugated polymerized birch pollen allergen extract in the concentration of 10 000 mTU/mL. The effect will be assessed by symptoms and medication need during the birch pollen season in April 2021.;Secondary Objective: The secondary objectives are: -To assess the safety and clinical tolerability of the treatment with Mannan conjugated polymerized birch pollen allergen extract in the concentration of 10 000 mTU/mL. -To assess the impact of the treatment with Mannan conjugated polymerized birch pollen allergen extract in the concentration of 10 000 mTU/mL on the immunological status of the patients. -To assess the clinical impact of the treatment with Mannan conjugated polymerized birch pollen allergen extracts in the concentration of 10 000 mTU/mL with regard to health-related Quality of Life. -To assess the clinical impact of the subcutaneous administration of mannan conjugated polymerized birch pollen allergen extract in the concentration of 10 000 mTU/mL in further treatment in 2021/2022. The effect will be assessed by symptoms and medication need during the birch pollen season in April 2022 and 2023. ;Primary end point(s): Primary endpoint: The clinical impact of the treatment with mannan conjugated polymerized birch pollen allergen extract in the concentration 10 000 mTU/mL will be assessed by the Combined Symptom and Medication Score (CSMS) over the peak pollen period in 2021. ;Timepoint(s) of evaluation of this end point: The Combined Symptom and Medication Score (CSMS) will be evaluated over the peak birch pollen period 2021. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: The safety and clinical tolerability assessment of the treatment with the Mannan conjugated polymerized birch pollen allergen extract in the concentration 10 000 mTU/mL will be assessed by: - Solicited adverse events o Local reactions at the injection site (wheal and redness) o 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, clinical chemistry, renal and liver function-related parameters) - Pulmonary function testing for asthmatic patients - Use of rescue medication during treatment phases 2020/2021 and 2021/2022. Clinical immunogenicity endpoints will include: - Induction of birch pollen-specific immuno-globulins IgE, IgG and IgG4 Clinical impact endpoints will include: - The Combined Symptom and Medication Score (CSMS) over the peak birch pollen seasons 2022 and 2023 - The Combined Symptom and Medication Score (CSMS) over the birch pollen seasons in April 2021, 2022 and 2023 - The mean daily Symptom Score (dSS) over the birch peak pollen season and the birch pollen seasons in April 2021, 2022 and 2023 - The mean daily Medication Score (dMS) over the birch peak pollen season and the birch pollen seasons in April 2021, 2022 and 2023 ;Timepoint(s) of evaluation of this end point: Solicited AEs will be evaluated between V2 - V7 and V10 - V15, unsolicited AEs and SAEs between V1 and V20. Physical examinations and vital signs will be evaluated between V1 - V20. Safety laboratory investigations will be done at V1 and V7. The use of rescue medication during the treatment phase will be evaluated between V2 - V6 and V10 - V14. Immunogenicity endpoints will be measured at V1, V7, V10, V15 and V18. CSMS will be evaluated over the pollen seasons in April 2021, 2022 and 2023. RQLQ will be evaluated at V7, V8, V15, V16, V18 and V19. | — |
Countries
Germany
Contacts
Public ContactContract Research Organisation
ClinCompetence Cologne GmbH
Outcome results
None listed