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: 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 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 laborator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;Primary 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.;Timepoint(s) of evaluation of this end point: The Combines Symptom and Medication Score (CSMS) will be evaluated over the peak birch pollen season 2022. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 Optional: - 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) ;Timepoint(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. | — |
Countries
Germany
Contacts
Public ContactContract Research Organisation
ClinCompetence Cologne GmbH
Outcome results
None listed