Patients suffering from allergic rhinitis/rhinoconjunctivitis related to birch pollen (with or without concomitant mild to moderate persistent asthma). MedDRA version: 14.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: SUBLIVAC FIX Birch 3.333 AUN/ml
Product Code: SUBLIVAC FIX Birch
Pharmaceutical Form: Oromucosal drops
INN or Proposed INN: allergen extract of Betula verrucosa
Current Sponsor code: SUB
Sponsors
HAL Allergy B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Age =18 = 60 years 3. Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma 4. FEV1>70% for patients with a history of asthma, FEV>70% or PEF>80% for patients without a history of asthma 5. A positive SPT (mean wheal diameter = 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization. 6. Positive serum specific anti-birch IgE-test (>0.7 U/mL) 7. A positive TNPT for birch pollen at screening (Lebel score =6) at =10,000 AU/mL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter = 3mm) to allergens other than birch pollen 2. Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets 3. Completed immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years 4. Completed unsuccessful specific immunotherapy in the past 5. Vaccination within one week before start of therapy or during the initiation phase 6. Anti-IgE therapy within the 6 months prior to inclusion and during the study 7. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs 8. Active malignancies or any malignant disease during the previous 5 years 9. Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders 10. Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study 11. Moderate to severe nasal obstructive diseases that preclude a TNPT (septal deviation, nasal polyps, recent nasal surgery, etc.) 12. Diseases with a contraindication for the use of Adrenaline (e.g. hyperthyroidism, glaucoma) 13. Use of systemic steroids within 4 weeks before start of the study and during the study 14. Treatment with systemic and local ß-blockers 15. Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study 16. Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or –pill) 17. Alcohol, drug or medication abuse within the past year 18. Any clinically significant abnormal laboratory parameter at screening 19. Lack of cooperation or compliance 20. Severe psychiatric, psychological, or neurological disorders 21. Patients who are employees of the institution or 1st grade relatives or partners of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the optimal effective dose of SUBLIVAC FIX Birch (SB) based on reduction of upper airways reactivity assessed by TNPT after 5 months of treatment with different dosages of SB compared to placebo. Coprimary objective: Difference in proportions of patients not reaching maintenance dose within 10 days due to related AEs of different dosages of SB compared to placebo.;Secondary Objective: • Safety and tolerability of different dosages of SB compared to placebo assessed by local and systemic reactions. • Changes in serum specific immunoglobulin levels after 5 months of treatment with different dosages of SB compared to placebo. • Changes in PNIF after 5 months of treatment with different dosages of SB compared to placebo. ;Primary end point(s): The primary endpoint is the absolute difference in mean total symptom score in the TNPT between 5 months of treatment and baseline. The differences in mean symptom score of the active dose groups and placebo will be compared in a step-down pairwise comparison starting with the highest dose ;Timepoint(s) of evaluation of this end point: After 5 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability of different dosages of SB vs. placebo will be assessed by number and severity of immediate and delayed local and systemic reactions. Immunogenicity of different dosages of SB (vs. placebo) after 5 months of treatment will be determined by serum specific immunoglobulin levels. At baseline and the end of the study visit a blood sample will be drawn for determination of specific IgE, IgG and IgG4 to birch. Changes in specific immunoglobulin levels before and after 5 months of treatment will be determined Changes in PNIF as a parameter of nasal patency will be determined following TNPT in patients receiving different dosages of SB compared to placebo ;Timepoint(s) of evaluation of this end point: After 5 months of treatment. | — |
Countries
Czech Republic, Germany, Poland
Contacts
Public ContactClinical Trial Management
HAL Allergy B.V.
Outcome results
None listed