PURETHAL Birch RUSH Study

Study Overview
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Brief Summary
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This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks). The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes. A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.

Official Title
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A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Birch Given With a Rush Up-dosing Regimen to Patients With Allergic Rhinitis/Rhinoconjunctivitis

Conditions
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Allergic Rhinitis, Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: PURETHAL Birch, 20.000 AUM/ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Age ≥12 years. Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma FEV1>70% for patients with a history of mild to moderate asthma, FEV1>70% or PEF>80% for patients without a history of asthma A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen. Positive serum specific anti-birch IgE-test (>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization. Exclusion Criteria: Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years Any specific immunotherapy (SCIT or SLIT) during the study period Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs Active malignancies or any malignant disease within the past 5 years Severe uncontrolled diseases that could increase the risk for patients participating in the study Acute/active inflammation or infection of the target organs at the start of the study Secondary changes of the target organ Diseases with a contraindication for the use of adrenaline Use of systemic steroids within 4 weeks before start of the study and during the study Treatment with systemic and local β-blockers Vaccination within one week before start of therapy or during the initiation phase Anti-IgE therapy within the 6 months prior to inclusion and during the study 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 Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age Alcohol, drug or medication abuse within the past year Any clinically significant abnormal laboratory parameter at screening Lack or expected lack of cooperation or compliance Severe psychiatric, psychological, or neurological disorders Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional regimen of PURETHAL Birch<br>Initial treatment: 6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml PURETHAL Birch, 20.000 AUM/ml (week 1, 2, 3, 4, 5, 6). Maintenance treatment: 0.5 ml PURETHAL Birch, 20.000 AUM/ml, in intervals according to registered scheme (week 8, 10, 12). | Biological: PURETHAL Birch, 20.000 AUM/ml<br>* comparison of different up-dosing regimes<br>|
| Experimental: rush regimen of PURETHAL Birch<br>Initial treatment: 3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml PURETHAL Birch, 20.000 AUM/ml (week 1, 2, 3) Maintenance treatment: 0.5 ml PURETHAL Birch, 20.000 AUM/ml, in 2-weekly intervals (week 5, 7, 9). | Biological: PURETHAL Birch, 20.000 AUM/ml<br>* comparison of different up-dosing regimes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients successfully reaching the maintenance dose |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early and late local and systemic reactions |  | 30 minutes after IMP injection and 24 hours after injection | 
| Immunological parameters (IgE, IgG) |  | 10 weeks rush regime, 13 weeks conventional regime | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, birch pollen, seasonal allergy, up-dosing