Patients suffering from seasonal allergic rhinoconjunctivitis with or without controlled asthma during the birch and grass pollen season MedDRA version: 17.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 17.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Allergovit® grasses
Product Name: Allergovit® grasses
Product Code: 553a/91a-b
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: ALLERGOVIT® grasses
CAS Number: 8000045-
Sponsors
Allergopharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has the patient given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.) 2. Is the patient a legally competent male or female outpatient? 3. Is the patient aged 18 to 65 years? 4. Does the patient suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma caused by grass pollen and birch pollen allergy documented by a) Skin prick test wheal for grass pollen = 3mm in diameter b) Skin prick test wheal for birch pollen = 3mm in diameter c) Histamine wheal = 3mm d) NaCl control reaction 0.70 kU/L to grass pollen allergens? b) for sIgE > 0.70 kU/L to birch pollen allergens? 6. Has the patient main discomfort due to allergic rhinoconjunctivitis in the months with respective grass pollen and birch pollen exposure? 7. Has the asthma status been checked? 8. Has the patient been treated with anti-allergic medications for at least 2 years prior to enrolment? Prior to the treatment phase the Sponsor will assess following criterion: 9. Does the patient suffer from relevant symptoms (adj. AUC of TNSS of at least 10) documented during the pre-treatment exposure with birch pollen allergens in the ECC? 10. Does the patient suffer from relevant symptoms (adj. AUC of TNSS of at least 10) documented during the pre-treatment exposure with grass pollen allergens in the ECC? 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 280 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General criteria: 1. Is the patient unable to understand and comply with the requirements of the trial, as judged by the investigator? 2. Is the patient currently participating in any other trial or has the patient participated in any other trial within 30 days before inclusion in this trial? 3. Does the patient show low compliance or inability to understand instructions/trial documents? 4. Is/was the patient involved in the planning and conduct of the trial? 5. Is the patient an employee of Allergopharma GmbH & Co. KG or of one of the trial sites? 6. Is the patient in any relationship of dependence with the sponsor and/or with the investigator? 7. Has the patient been previously enrolled or randomised to treatment in the present trial? 8. Is the patient mentally disabled? 9. Is the patient institutionalised due to an official or judicial order? For females with childbearing potential (i.e. females who are not chemically or surgically sterilised or females who are not post-menopausal): 10. Does the patient have a positive pregnancy test at screening? 11. Does the patient use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator? (Reliable and highly effective methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correctly are, e.g., implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partners.) 12. Does the patient wish to breast feed? 13. Is the patient seeking to become pregnant during the course of the study? Immunotherapy criteria: 14. Has the patient undergone previous specific immunotherapy with grass pollen or birch pollen allergens in any formulation? 15. Is the patient currently undergoing any sort of specific immunotherapy? 16. Has the patient ever undergone specific immunotherapy with unknown allergens? Diseases and health status: 17. Does the patient suffer from clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons which interfere with the assessments in the ECC? 18. Has the patient a PEF/FEV1 < 80% of predicted normal (ECSC)? 19. Has the patient uncontrolled or partly controlled asthma according to GINA 2012? 20. Does the patient suffer from perennial and continuously treated asthma? 21. Does the patient suffer from rhinoconjunctival atopy symptoms for 20 years or longer? 22. Does the patient suffer from severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)? 23. Does the patient suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], Grave’s disease)? 24. Does the patient suffer from severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)? 25. Does the patient suffer from recurrent seizures? 26. Has the patient an anatomic abnormality that interferes with assessment of Total Nasal Symptom Score (TNSS) if being assessed in the environmental challenge chamber? 27. Has the patient any laboratory value greater than Grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials)? Medications: 28. Is the patient permanently needing any me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to demonstrate a specific treatment effect for ALLERGOVIT® grasses and ALLERGOVIT® birch. ;Secondary Objective: The main secondary objective of this study is to assess the superiority of the specific treatment effect of SCIT compared to the unspecific treatment effect. Please refer to section 5.2 for further objectives;Primary end point(s): • Specific treatment effect of ALLERGOVIT® grasses • Specific treatment effect of ALLERGOVIT® birch ;Timepoint(s) of evaluation of this end point: Evaluation after database lock approx. Feb 2016 under blended conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Key secondary endpoint Specific treatment effect of SCIT compared to the unspecific treatment effect of SCIT for both treatments Further secondary efficacy endpoints • Unspecific treatment effect of ALLERGOVIT® grasses • Unspecific treatment effect of ALLERGOVIT® birch • Specific treatment effect of ALLERGOVIT® grasses compared to the unspecific treatment effect of ALLERGOVIT® grasses • Specific treatment effect of ALLERGOVIT® birch compared to the unspecific treatment effect of ALLERGOVIT® birch • Change from baseline in birch and grass pollen IgG4 in patients treated with ALLERGOVIT® grasses • Change from baseline in birch and grass pollen IgG4 in patients treated with ALLERGOVIT® birch • Severity of allergic symptoms in the grass pollen season and the birch pollen season measured by a Visual Rating Scale (VRS) in patients treated with ALLERGOVIT® grasses • Severity of allergic symptoms in the grass pollen season and the birch pollen season measured by a Visual Rating Scale (VRS) in patients treated with ALLERGOVIT® birch • Quality of life in the grass pollen season and the birch pollen season measured by the SF-12 in patients treated with ALLERGOVIT® grasses • Quality of life in the grass pollen season and the birch pollen season measured by the SF-12 in patients treated with ALLERGOVIT® birch Safety and tolerability Safety of treatment during the entire trial period will be assessed by • Adverse events • Clinical laboratory tests (hematology, clinical chemistry and urinalysis) • Vital signs (resting blood pressure, pulse rate and respiratory rate) • An assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932) ;Timepoint(s) of evaluation of this end point: Evaluation after database lock approx. Feb 2016 under blended conditions | — |
Countries
Germany
Contacts
Public ContactPD Dr. med Dietrich Häfner
Allergopharma GmbH & Co. KG
Outcome results
None listed