Seasonal allergic rhinoconjunctivitis due to birch pollen MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000014962
Conditions
Interventions
Product Name: Pollinex Quattro Birch (900SU/ml)
Product Code: V01A A05
Pharmaceutical Form: Suspension for injection
Other descriptive name: BIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
Concentrat
Sponsors
Allergy Therapeutics (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent available. 2. Male or female aged 18 to 60 years inclusive at the time of signing the consent form. 3. Female patients are allowed to participate in the study if they are: i. Not of childbearing potential, defined as: post-menopausal (defined as natural spontaneous amenorrhea for at least 12 months, or at least 6 weeks following surgical menopause), or ii. Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study screening). iii. Non-pregnant, non-lactating with negative urinary pregnancy test at all visits leading up to randomisation and using at least one of the following contraceptive methods: a) Stable hormonal contraceptive for = 90 days prior to the study and for at least 7 days after the final injection. If =65 years) no F.1.3.1 Number of subjects for this
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating. 2. Positive SPT (wheal [longest diameter] = 3 mm) at V1 to: a) Ash (Fraxinus excelsior). b) Grass pollen mix. Exception: Patients with no positive case history of moderate to severe symptoms at any time during the 3 years prior to visit*1 may be enrolled. c) House dust mites (Dermatophagoides pteronyssinus or Dermatophagoides farinae) or moulds (Alternaria alternata). Exception: Patients with no positive case history of moderate to severe symptoms at any time during the 3 years prior to V1 may be enrolled. d) Epithelia (cat fur and dog hair). Exception: Patients with no positive case history of moderate to severe symptoms at any time during the 3 years prior to Visit1 or patients who can avoid the allergen of concern for the duration of the trial may be enrolled. e) Mugwort (Artemisia vulgaris), English plantain (Plantago lanceolata) or Ragweed (Ambrosia elatior) with a positive case history of moderate to severe symptoms during the 3 years prior to Visit 1. Exc.: The patient can return for the treatment period after end of the relevant pollen season. Testing not required if the allergen is uncommon to the region or the allergy season is over at the time of screening or treatment. 3. Moderate to severe symptoms to another seasonal or perennial allergen not listed in exclusion criterion 2 that cannot be avoided and the symptoms of which may interfere with administration of treatment and/or impact the data collected during the BPS. 4. History of immunological disorders or other diseases that may pose a safety risk or compromise the interpretation of efficacy of the study treatment. 5. Presence of moderate to severe asthma, characterised by the requirement to use of inhaled steroids at a daily dose budesonide >400 µg or equivalent. 6. Emergency room visit or hospitalisation for asthma in the 12 months prior to Visit 1 or any history of a life-threatening asthma attack. 7. Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps). 8. Presence of any skin conditions which might interfere with the interpretation of the SPT results. 9. Current diagnosis of type I diabetes. Patients with type II diabetes will only be allowed to participate at the discretion of the investigator. 10. History of allergen-specific immunotherapy (SIT). Exc.: The SIT occurred > 5 years prior to Visit 1, at least one full annual course of SIT was completed, and a successful effect on symptom control was observed for at least 1 pollen season after treatment. 11. Treatment with a preparation containing MPL® within 6 months prior to Visit 1 and, with the exception of study drug, until after completion of Visit 10/10a. 12. Any acute infection (including upper respiratory tract infections) within 14 days of Visit 2. 13. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, drugs, idiopathic anaphylaxis or physical exercise. 14. Clinical history of any allergy, hypersensitivity to or intolerance of the excipients of the study medication. 15. Tyrosine metabolism disorders, especially tyrosinaemia and alkaptonuria. 16. Inability to adhere to washout periods listed in table Prohib. Medications/Therapies with respect to V1 and V2 and to refrain from using the medications indicated from V2 until after completion of V10/10a except of relief medications. 17.Inability to receive epinephrine therapy. 18.Beta blocker medication, including eye drops, for any indicati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of PQ Birch in birch pollen-induced rhinoconjunctivitis.;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability of PQ Birch in birch pollen-induced rhinoconjunctivitis. ;Primary end point(s): The primary endpoint is the total combined symptom medication score (CSMS) of the rhinoconjunctivitis daily symptom score (dSS) and rhinoconjunctivitis daily medication score (dMS), averaged over the peak birch pollen season (BPS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: The key secondary efficacy endpoints are: 1. The average rhinoconjunctivitis CSMS over the entire BPS 2. The average rhinoconjunctivitis daily symptoms scores (dSS) and dMS separately averaged over the peak and entire BPS 3. The average rhinoconjunctivitis CSMS during the BPS based on the peak placebo-score period (26) 4. The probability of well days and severe days during the peak and entire BPS 5. The change in immunological responses (total IgE, specific IgE, IgG and IgG4, specific IgE/total IgE ratio) between screening and Visit 10/10a 6. The change in quality of life as assessed by the RQLQ(s) over the entire BPS Safety/Tolerability: The key safety endpoints are: 1. Frequency, severity and relationship of AEs 2. Frequency and intensity of ARCs (defined by the maximum intensity of all injection site (local) and systemic AEs experienced by a patient within a 24-hour period after any injection) 3. Frequency of premature discontinuation from treatment or study due to AEs 4. Changes in clinical laboratory values (chemistry, haematology, urinalysis) between screening and Visit 10/10a 5. Changes in vital sign parameters at all visits during the treatment period between pre-injection and post-injection Safety/Tolerability: The key safety endpoints are: 1. Frequency, severity and relationship of AEs 2. Frequency and intensity of ARCs (defined by the maximum intensity of all injection site (local) and systemic AEs experienced by a patient within a 24-hour period after any injection) 3. Frequency of premature discontinuation from treatment or study due to AEs 4. Changes in clinical laboratory values (chemistry, haematology, urinalysis) between screening and Visit 10/10a 5. Changes in vital sign parameters at all visits during the treatment period between pre-injection and post-injection | — |
Countries
Austria, Germany, Poland, Sweden
Contacts
Public ContactClinical Research Management
Bencard Allergie GmbH
Outcome results
None listed