Adult patients, 18-65 years of age, suffering from moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons. MedDRA version: 19.1 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: AllerT
Pharmaceutical Form: Powder for injection
INN or Proposed INN: not established
CAS Number: none
Current Sponsor code: AllerT1
Other descriptive name: AllerT1
Concentration unit: µ
Sponsors
ANERGIS SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged 18 to 65 years 2. Subjects presenting moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen confirmed at screening by all of the following criteria: a. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) = 12 during the two consecutive preceding birch pollen seasons based on subject’s interview by the investigator b. Previous use of anti-allergy medications during the two preceding birch pollen seasons based on subject’s interview by the investigator c. Positive SPT to birch pollen extract (wheal = 5 mm larger than the diluent control) d. Positive specific IgE CAP test for Bet v 1 (= 3 kU/L) 3. Women of childbearing potential under continuous effective contraception during the treatment period a. This includes: established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; true abstinence (periodic abstinence and withdrawal are not acceptable) or vasectomised male partner, provided that he is the sole partner of that subject. 4. Subjects having been informed and having provided signed consent for participating in the trial and willing to follow all planned trial assessments Included subjects must not be entered more than once into the trial. 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Received specific immunotherapy against: a. Any allergen within five (5) years before the screening visit b. Birch pollen or a tree pollen mix including birch pollen at any time before the screening visit 2. Clinical symptoms due to allergens other than birch pollen during the expected birch pollen season (e.g. perennial allergies, allergies to other pollens with a season overlapping the birch pollen season). Patients sensitized to alder and/or hazel may be included provided that the clinical symptoms is caused by their birch allergy. 3. Persistent non-controlled asthma; subjects with a Forced Expiratory Volume (FEV1) lower than 85% of predicted value (see FEV1 predicted and 85% of predicted values in Appendix 12.3) and/or subjects under chronic treatment for asthma. Subjects with seasonal asthma may be included if they are controlled with beta-2-agonist and low dose inhaled corticosteroid (below or equal to budesonide 400 micro-gram on a daily basis). 4. History of severe anaphylactic reaction (grade 4 reaction as per the definitions given in Appendix 12.1) 5. History of any debilitating disease and/or severe medical condition able to influence the course of the trial or the ability of the subjects to fulfill the requirements of the trial 6. Any confirmed or suspected primary or secondary immunodeficiency condition, including human immunodeficiency virus (HIV) infection and asplenia 7. Pregnant or lactating women or women willing or intending to become pregnant during the trial 8. Suspected or known current alcohol or any drug abuse 9. Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the trial 10. Subjects intending to travel during the birch pollen season outside of the birch pollination area for more than seven consecutive days 11. Subjects unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device 12. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities 13. Beta-blockers or ACE-inhibitors within four weeks prior to randomization, or planned to be used during the treatment period 14. Immunosuppressive medication (including steroids) within four weeks prior to randomization, or planned to be used during the trial period 15. Use of anti-depressant medication with antihistamine effect within two weeks prior to randomization 16. Use of any investigational or non-registered drug, vaccine or medical device within four weeks prior to randomization, or planned to be used during the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 50 µg maintenance dose compared to placebo in reducing symptoms of and medication use in allergic Rhinitis/Rhinoconjunctivitis during the following birch pollen season;Secondary Objective: To demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 10 µg maintenance dose in reducing symptoms of and medication use in allergic Rhinitis/Rhinoconjunctivitis during the following birch pollen season To evaluate the safety and tolerability of a two months pre-seasonal treatment with AllerT at maintenance doses of 50 µg and of 10 µg To evaluate the effects of a two months pre-seasonal treatment with AllerT at maintenance doses of 50 µg and 10 µg during the following birch pollen season on: o Subjects' quality of life o Other clinical endpoints including night-time symptoms, number of well days, number of days with severe symptoms and subject’s global evaluation of treatment efficacy;Primary end point(s): The primary efficacy variable is the average of the combined Rhinoconjunctivitis Symptom and Medication Score (CSMS) obtained daily during the birch pollen season.;Timepoint(s) of evaluation of this end point: Start day of birch pollen season until end day of birch pollen season. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Average of the total score of the quality of life questionnaires obtained weekly during the birch pollen season using the validated Mini-RQLQ questionnaire Average of the Night-time Nasal Symptom Score (NNSS) obtained daily during the birch pollen season Average of the combined Rhinoconjunctivitis and Night-time Symptom and Medication Score (CNSMS) obtained daily during the birch pollen season Percent of Well Days during the birch pollen season Percent of Days with Severe Symptoms during the birch pollen season Subject’s global evaluation of treatment efficacy collected at the end of the birch pollen season both on a categorical scale as well as on a VAS;Timepoint(s) of evaluation of this end point: Start day of birch pollen season until end day of birch pollen season. | — |
Countries
Denmark, Finland, Germany, Lithuania, Poland, Slovakia
Contacts
Public ContactChief Development Officer
ANERGIS SA
Outcome results
None listed