Patients with birch pollen-related allergic rhinitis/rhinoconjunctivitis and with well-controlled mild-to-moderate or without asthma MedDRA version: 21.1 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10010744 Term: Conjunctivitis allergic System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: CLUSTOID Birke
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
ROXALL Medizin GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: The secondary objective of the study is to support the evaluation of the efficacy of each dose treatment with CLUSTOID Birke compared to placebo;Primary 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. ;Timepoint(s) of evaluation of this end point: 10.07.2023 to 20.08.2025 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 | — |
Countries
Germany, Kazakhstan, Serbia, Turkey, Ukraine
Contacts
Public ContactMedical Manager
ROXALL Medizin GmbH
Outcome results
None listed