seasonal allergic rhinoconjunctivitis due to birch pollen MedDRA version: 17.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: POLLINEX Quattro® Birch
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: birch pollen allergen extract
Other descriptive name: BIRCH POLLEN MODIFIED ALLERGEN TYROSINE-A
Sponsors
Allergy Therapeutics (UK) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years inclusive. 2. Allergy to birch pollen allergen, defined by: • A positive case history of moderate to severe symptoms of seasonal allergic rhinoconjunctivitis ascribed to birch pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers in at least the last 2 years; • A positive skin prick test (SPT) for birch pollen allergen (wheals of = 3 mm greater than the negative control after skin prick testing) at Visit 1. 3. Positive SPT to histamine [wheal (longest diameter) = 3 mm greater than the negative control]. 4. Negative SPT to the negative control (redness with wheal = 2 mm is acceptable). 5. Positive CPT at Visit 1 6. Forced expiratory volume (FEV) in 1 second (FEV1) = 80% of predicted, with a FEV1/forced vital capacity (FVC) ratio = 70%. 7. Adhere to the drug washout times prior to Screening (Visit 1 and 1a, if applicable). The use of other medications will be permitted if they are not expected to interfere with the ability of the subject to participate in the study and provided they have been on a stable regimen (i.e., the same dosage and administration) for 6 weeks prior to Screening. 8. Males or non-pregnant, non-lactating females 9. Normally active and otherwise judged to have an acceptable health status on the basis of medical history, physical examination and routine laboratory tests. 10. Willing and able to give written informed consent and must provide this consent. 11. Able to understand and comply with study instructions. 12. Willing and able to attend required study visits. 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 140 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Any acute, chronic and/or infectious ocular disorder (other than allergic conjunctivitis) which could interfere with the evaluation of the study medication. 2. Moderate to severe asthma, defined by: • asthma requiring the daily use of controller medication or; • emergency room visit or admission for asthma in the 12 months prior to Visit 1. 3. Presence of secondary alteration at the affected organ (i.e., emphysema, bronchiectasis, nasal polyps, chronic sinusitis). 4. Any skin conditions which might interfere with the interpretation of the SPT results. 5. Current diagnosis of Type I diabetes. Subjects with Type II diabetes will only be allowed to participate at the discretion of the Investigator. 6. Presence or history of auto-immune disease 7. History of cancer or concomitant illness (e.g., cardiovascular, pulmonary, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic, or psychiatric diseases or disorders) that, in the opinion of the Investigator, would pose a safety risk or compromise the interpretation of efficacy for this birch immunotherapy. 8. Chronic use of inhaled, nasal, ocular, oral, intramuscular, intravenous, or potent or superpotent topical corticosteroids (as assessed by the Investigator). 9. Chronic use of long acting antihistamines and other concomitant medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of study drug(s). 10. Positive SPT [wheal (longest diameter) = 3 mm greater than the negative control] at Visit 1 to any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), moulds (Alternaria alternata), or epithelia (cat and dog) and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 11. Positive SPT [wheal (longest diameter) = 3mm greater than the negative control] at Visit 1 to grass pollen mix and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 12. Positive SPT [wheal (longest diameter) = 3mm greater than the negative control] at Visit 1 to any of the following autumn flowering plant allergens: mugwort (Artemisia vulgaris), English plantain (Plantago lanceolata) or ragweed (Ambrosia sp.) and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 13. Any systemic disorder that could interfere with the evaluation of the study medication(s). 14. Acute or chronic infection or inflammation. 15. Upper or lower respiratory airway infection requiring antibiotics within 14 days of Visit 2 and a diagnosis of sinusitis within 30 days of Visit 2. 16. Manifest pulmonary or cardiac insufficiency. 17. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication. 18. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis. 19. Clinical history of immunodeficiency, including those who are on immunosuppressant therapy. 20. Diseases with a pathogenesis interfering with the immune response and who have received medication which could influence the results of the study. 21. Clinical history of recurrent idiopathic angioedema or hereditary angioedema. 22. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria. 23. Beta-blocker medication, in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the difference in change (baseline to post-treatment) in total symptom score (TSS) recorded following application of a CPT between four POLLINEX Quattro® Birch treatment arms of 600SU, 1550SU, 5100SU and 13600 (cumulative doses), respectively.;Secondary Objective: Efficacy: 1. To compare proportions of subjects with negative CPT after treatment between four POLLINEX Quattro® Birch treatment arms 2. To compare change (baseline to post-treatment) in allergen concentration required for eliciting of a positive CPT 3. To compare change (baseline to post-treatment) in individual symptom scores (ISS) between four POLLINEX Quattro® Birch treatment arms 4. To compare immunological (Birch specific IgG, IgG4 and IgE) differences (baseline to post-treatment) between four POLLINEX Quattro® Birch treatment arms Safety/Tolerability: 1. To compare the tolerability of different subcutaneous doses. 2. To compare the tolerability of cumulative subcutaneous doses . 3. To compare the frequency of adverse events (AEs). 4. To compare the frequency of adverse reaction complexes (ARCs) 5. To compare the proportion of subjects not completing the treatment regimen due to AEs. 6. To compare changes in routine clinical laboratory values and vital signs.;Primary end point(s): Change from baseline to post-treatment in TSS following CPT;Timepoint(s) of evaluation of this end point: Visit 2/2a (baseline) and Visit 8 (post-treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: ? Proportion of subjects with negative CPT post-treatment ? Number of additional allergen concentration steps required to elicit a positive CPT post-treatment ? Change from baseline to post-treatment in individual symptom scores (ISS) following CPT ? Immunological changes to immunoglobulins (birch specific IgG, IgG4 and IgE) Safety: ? Tolerability of different subcutaneous doses ? Tolerability of cumulative subcutaneous doses (i.e. dose regimens) ? Frequency of AEs ? Frequency of ARCs (the total of treatment related injection site and systemic AEs experienced by a subject within a 24-hour period after an injection) ? Premature discontinuation from treatment or study due to AEs ? Clinical laboratory values (chemistry, haematology, urinalysis) ? Vital signs ;Timepoint(s) of evaluation of this end point: Efficacy: - Visit 8 - Visit 8 - V2/2a and V 8 - V 1 and V 8 Safety: during the whole course of the study | — |
Countries
Austria, Germany, Poland
Contacts
Public ContactClinical Research Management
Bencard Allergie GmbH
Outcome results
None listed