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
Interventions
Product Name: T502 1,000mTU/mL
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: T502
CAS Number: 8000045-25-2
Current Sponsor code: T502
Other descriptive name: ALLERGENS, POLLEN & P
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 or male patients aged 18–64 years, • Being in good physical and mental health, • Confirmed normal renal and liver function (including non-clinically significant deviations as defined per laboratory ranges), • For females: non-pregnant, non-lactating with adequate contraception 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)). Adequate contraception comprises - Intake of oral contraceptive + condom - Intrauterine device + hormone addistive or depot-hormone preparation (injection) - Condom with or without spermicide + diaphragm with spermicide - Vaginal ring + condom - Hormone patch + condom - Sterisilsation + condom or spermicide • Having the diagnosis of 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 [1]), - A positive skin prick test (SPT - wheal diameter = 3 mm) to birch pollen allergens, positive control (histamine) wheal = 3 mm, negative control (NaCl) wheal =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not meet any of the following non-inclusion criteria in order to participate in this study: • 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, • 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 (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), • 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 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 entire study period (e.g. against flu, pneumococae, etc) – 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 bowl disease, uncontrolled diabetes mellitus, etc. • Intake of antidepressant drugs with potent antihistamine properties suh 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), • Having any contraindication for NPT testing – see Section VIII.9.3 “Nasal Provocation Test”, • 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 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
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. ;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 the reduction of nasal tissue reactivity following a titrated Nasal Provocation Test (TNPT) and 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 pollen period 2020 between the placebo and the active treatment groups.;Timepoint(s) of evaluation of this end point: The Combined Symptom and Medication Score (CSMS) will be evaluated over the peak birch pollen period 2020. | — |
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 treatment phase Clinical immunogenicity endpoints will include: - Production of birch pollen-specific immunoglobulins IgE, IgG and IgG4 Optional: - Production of Blocking Antibodies (FAB assay, assessed in a subset of 50 patients) Clinical impact endpoints will include: - The Combined Symptom and Medication Score (CSMS) over the entire birch pollen season 2020 - 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 - The proportion of patients with a reduction of reactivity in TNPT from V1 to V7 between placebo and the active treatment groups. The reduction of reactivity will be measured by the allergen concentration threshold needed to elicit a positive NPT response. - Reduction of reactivity in TNPT from V1 to V7 - Improvement in peak nasal inspiratory flow from V1 to V7 and V8 - Differences between placebo- and actively treated patients in health-related Quality of Life during the birch pollen season (V7, V8) - Rhinitis symptom control at the peak of the birch pollen season (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 visits V1 and V7. FEV1/PE | — |
Countries
Germany
Contacts
Public ContactContract Research Organisation
ClinCompetence Cologne GmbH
Outcome results
None listed