Seasonal allergic rhinoconjunctivitis due to birch pollen MedDRA version: 18.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: Pollinex Quattro Birch (300 SU/mL)
Pharmaceutical Form: Suspension for injection
Other descriptive name: BIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
Concentration unit: SU Standard
Sponsors
Allergy Therapeutics (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 60 years inclusive at the time of signing the consent form. 2. Female subjects are allowed to participate in the study if they are: -Not of childbearing potential defined as: postmenopausal (defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause) or -Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). -Non-pregnant, non-lactating with negative urinary pregnancy test at all visits leading up to randomisation and who use at least one of the following effective contraception options: • Established use (= 90 days prior to the study) of hormonal contraceptive. If < 90 days, additional use of one other effective contraception method until 90 days exceeded or, • Placement of an intrauterine device or intrauterine system or, • Use of double barrier methods of contraception (e.g. male condom with diaphragm, male condom with cervical cap) or, • Successful male sterilization of the sole partner (subject must verbally confirm that appropriate post-vasectomy documentation of the absence of sperm in the ejaculate was provided after the procedure) or, • True abstinence, when in line with the preferred and usual lifestyle of the subject. Periodic abstinence, such as calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception. 3. Good general health, as determined by the investigator, based on a medical evaluation, including medical history, physical examination and laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. 4. Positive history of moderate to severe seasonal allergic rhinoconjunctivitis ascribed to birch pollen exposure, requiring treatment for at least the last 2 years prior to the study and severe symptoms of allergic rhinoconjunctivitis in the past birch pollen season as determined by a score of = 5 on the Disease Severity Questionnaire (DSQ). 5. A positive SPT for birch (wheals of = 3 mm greater than the negative control and histamine (wheal [longest diameter] = 3 mm greater than the negative control) and a negative SPT to the negative control (redness with wheal < 2 mm is acceptable) at screening. 6. Birch-specific IgE = 2 as documented by a CAP or equivalent specific IgE test at screening. 7. Positive CPT at Visit 1 or 1a (TSS = 6, adjusted for reference eye score), and positive CPT at Visit 2 to the same birch extract allergen concentration reached at Visit 1. Note: If CPT at Visit 2 is negative, increase allergen concentration step-wise according to procedure until positive test is achieved. If the result can be verified at a second CPT visit within 6-8 days of Visit 2 (i.e. Visit 2a), the subject may be included. 8. Forced expiratory volume (FEV) in 1 second (FEV1) = 80% of predicted, with a FEV1/forced vital capacity (FVC) ratio = 70% at screening. 9. The use of medications not excluded in Exclusion Criterion 13will 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 wee
Exclusion criteria
Exclusion criteria: 1. History of immunological disorders or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment. 2. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis, which could interfere with the evaluation of the CPT. 3. Presence of moderate to severe asthma, characterised by the current use of inhaled steroids at a daily dose above 200 mcg bd and as defined in the Global Initiative for Asthma (GINA) guidelines. 4. Presence of any skin conditions which might interfere with the interpretation of the SPT results. 5. Current diagnosis of Type I or II diabetes. 6. History of allergen-SIT. Exception: the SIT occurred > 5 years before Visit 1, at least one full annual course of SIT was completed and successful effect on symptom control for at least 1 pollen season after treatment was observed. 7. Treatment with a preparation containing MPL® within 6 months prior to Visit 1. 8. Moderate to severe upper or lower respiratory infections requiring medication within 14 days of Visit 2 or a diagnosis of sinusitis within 30 days of Visit 2. 9. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis. 10. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication. 11. Tyrosine metabolism disorders, especially tyrosinaemia and alkaptonuria. 12. 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 (refer to Symptom Intensity Assessment in Section 10.4.4). Exception: Subjects verifying moderate to severe symptoms to cat or dog may be enrolled if the allergen of concern can be avoided until after the post-treatment visit (Visit 8). -grass pollen mix and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 (refer to Symptom Intensity Assessment Section 10.4.4). Note: Subjects verifying moderate to severe symptoms to grass may return for re-screening 21 days following the end of grass pollen season and cessation of symptoms. No testing is required if screening occurs following the end of grass pollen season. - 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 (refer to Symptom Intensity Assessment Section 10.4.4). Note: Subjects verifying moderate to severe symptoms to any autumn flowering plant allergens may return for re-screening 21 days following the end of the relevant allergen season and cessation of symptoms, pending sufficient time for completion of treatment. One or more of the listed allergens must not be tested if uncommon to the Investigator’s region or, if common, screening and treatment can be performed after
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the difference between six individual POLLINEX® Quattro (PQ) Birch dose regimen of 5000 SU, 5100 SU, 15000 SU, 15300 SU, 20100 SU and 27300 SU (cumulative doses), and placebo, with regard to the change seen from baseline to post-treatment in TSS recorded following a CPT.;Secondary Objective: Efficacy: • To compare the effect of treatment with nearly identical cumulative doses of PQ Birch when administered as 4 versus 6 injections on TSS following CPT. • To assess the change in immunological responses following different short course PQ Birch treatments, as reflected by the levels of allergen specific immunoglobulins. Safety/Tolerability: • To assess the safety and tolerability of different short course PQ Birch treatments, including the frequency of adverse events (AE), adverse reaction complexes (ARCs); the total of treatment related injection site and systemic AEs experienced by a subject within a 24 hour period after an injection) and changes in routine clinical laboratory values (chemistry, haematology, urinalysis) and vital signs. • To assess the proportion of subjects not completing a treatment regimen due to AEs.;Primary end point(s): Change from baseline to post-treatment in TSS following CPT ;Timepoint(s) of evaluation of this end point: 77 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 77 days;Secondary end point(s): Secondary Efficacy Endpoints: · Number of additional allergen concentration steps required to elicit a positive CPT (i.e. TSS = 6, adjusted for reference eye score) post-treatment · Immunological changes to immunoglobulin levels (birch--specific IgE) Secondary Safety Endpoints: · 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 · Changes in clinical laboratory values (chemistry, haematology, urinalysis) between screening and Visit 8 · Changes in vital sign parameters at all visits in the treatment period between from preinjection to post-injection. | — |
Countries
Austria, Germany
Contacts
Public ContactClinical Research Management
Bencard Allergie GmbH
Outcome results
None listed