Grass pollen allergy
Conditions
Interventions
Product Code: BM32
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: BM321
Current Sponsor code: BM321
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Con
Sponsors
Biomay AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The subjects are grass pollen allergic but otherwise healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests. • They are aged 18 to 60 years inclusive. • They have a history of seasonal allergic rhinitis (SAR) to grass pollen. • They have a normal electrocardiogram without clinically significant abnormalities. • They exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as a nasal symptom score (TNSS) of at least 6. (Nasal symptom score is the sum of nasal obstruction, rhinorrhea, itchy nose and sneezing, each of which have been scored on a categorical scale from 0 to 3 as given in Appendix II). • They have a positive skin prick test with a wheal diameter over 4mm for grass pollen extract at the screening visit. • They have a positive serum IgE test for timothy grass pollen and to rPhl p 1+rPhl p 5 at the screening visit or within the previous six months (timothy grass (g6): ImmunoCAP IgE level = 3.5 kUA/l ; rPhl p 1/rPhl p 5 (g213): ImmunoCAP IgE level = 2.0 kUA/l) • There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours. • They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form. • They are available to complete all study measurements 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 ;Inclusion criteria: • The subjects are grass pollen allergic but otherwise healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests. • They are aged 18 to 60 years inclusive. • They have a history of seasonal allergic rhinitis (SAR) to grass pollen. • They have a normal electrocardiogram without clinically significant abnormalities. • They exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as a nasal symptom score (TNSS) of at least 6. (Nasal symptom score is the sum of nasal obstruction, rhinorrhea, itchy nose and sneezing, each of which have been scored on a categorical scale from 0 to 3 as given in Appendix II). • They have a positive skin prick test with a wheal diameter over 4mm for grass pollen extract at the screening visit. • They have a positive serum IgE test for timothy grass pollen and to rPhl p 1+rPhl p 5 at the screening visit or within the previous six months (timothy grass (g6): ImmunoCAP IgE level = 3.5 kUA/l ; rPhl p 1/rPhl p 5 (g213): ImmunoCAP IgE level = 2.0 kUA/l) • There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours. • They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form. • They are available to complete all study measurements 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 ;Inclusion criteria: • The subjects are grass pollen allergic but otherwise healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests. • They are aged 18 to 60 years inclusive. • They have a history of seasonal allergic rhinitis (SAR) to grass pollen. • They have a normal electrocardiogram without clinically significant abnormalities. • They exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as a nasal symptom score (TNSS) of at least 6. (Nasal symptom score is the sum of nasal obstruction, rhinorrhea, itchy nose and sneezing, each of which have been scored on a categorical scale from 0 to 3 as given in Appendix II). • They have a positive skin prick test with a wheal diameter over 4mm for grass pollen extract at the screening visit. • They have a positive serum IgE test for timothy grass pollen and to rPhl p 1+rPhl p 5 at the screening visit or within the previous six months (timothy grass (g6): ImmunoCAP IgE level = 3.5 kUA/l ; rPhl p 1/rPhl p 5 (g213): ImmunoCAP IgE level = 2.0 kUA/l) • There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours. • They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form. • They are available to complete all study measurements 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
Exclusion criteria
Exclusion criteria: • Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test). • They have a positive serum IgE test for rPhl p 7 at the screening visit or within the previous six months (ImmunoCAP IgE level =0,35 kUA/l) • They have a positive skin prick test for alternaria and this is confirmed by their ISAC sensitization profile • On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study. • Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists or low-dose inhaled corticosteroid and associated with normal lung function. • The subject is concurrently participating or has participated in any clinical study in the previous month. However, participation solely in the form of blood donation and/or without other interventions will be acceptable. • Participation in a SIT trial for grass pollen allergy in the three years prior to this study. • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). • Documented autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies as judged by the investigator • Suspected hypersensitivity to any ingredients of the study medication • Use of prohibited medication: o Depot corticosteroids – 12 weeks prior to Visit 1 o Oral corticosteroids – 8 weeks prior to Visit 1 o long-acting inhaled corticosteroids – 4 weeks prior to Visit 1 o depot corticosteroids or long-acting inhaled corticosteroids throughout the study o anti-histamines (histamine H1 blockers) three days prior to pollen chamber sessions • The subject is at risk of non-compliance with the study procedures/restrictions. • Allergic symptoms at the time of screening ;Exclusion criteria: • Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test). • They have a positive serum IgE test for rPhl p 7 at the screening visit or within the previous six months (ImmunoCAP IgE level =0,35 kUA/l) • They have a positive skin prick test for alternaria and this is confirmed by their ISAC sensitization profile • On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study. • Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists or low-dose inhaled corticosteroid and associated with normal lung function. • The subject is concurrently participating or has participated in any clinical study in the previous month. However, participation solely in the form of blood donation and/or without other interventions will be acceptable. • Participation in a SIT trial for grass pollen allergy in the three years prior to this study. • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). • Documented autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies as judged by the investigator • Suspected hypersensitivity to any ingredients of the study medication • Use of prohibited medication: o Depot corticosteroids – 12 weeks prior to Visit 1 o Oral corticosteroids – 8 weeks prior to Visit 1 o long-acting inhaled corticosteroids – 4 weeks prior to Visit 1 o depot corticosteroids or long-acting inhaled corticosteroids throughout the study o anti-histamines (histamine H1 blockers) three days prior to pollen chamber sessions • The subject is at risk of non-compliance with the study procedures/restrictions. • Allergic symptoms at the time of screening ;Exclusion criteria: • Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test). • They have a positive serum IgE test for rPhl p 7 at the screening visit or within the previous six months (ImmunoCAP IgE level =0,35 kUA/l) • They have a positive skin prick test for alternaria and this is confirmed by their ISAC sensitization profile • On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study. • Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists or low-dose inhaled corticosteroid and associated with normal lung function. • The subject is concurrently participating or has participated in any clinical study in the previous month. However, participation solely in the form of blood donation and/or without other interventions will be acceptable. • Participation in a SIT trial for grass pollen allergy in the three years prior to this study. • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). • Documented autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies as judged by the investigator • Suspected hypersensitivity to any ingredients of the study medication • Use of prohibited medication: o Depot corticosteroids – 12 weeks prior to Visit 1 o Oral corticosteroids – 8 weeks prior to Visit 1 o long-acting inhaled corticosteroids – 4 weeks prior to Visit 1 o depot corticosteroids or long-acting inhaled corticosteroids throughout the study o anti-histamines (histamine H1 blockers) three days prior to pollen chamber sessions • The subject is at risk of non-compliance with the study procedures/restrictions. • Allergic symptoms at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the level of allergen-specific IgG4 and IgG1 antibodies at the peak of the grass pollen season comparing the different dosing schedules of BM32 at the dose of 20µg per API with placebo. ;Secondary Objective: • effects of different dosing schedules of BM32 (at a dose of 20µg per API) compared to placebo by studying the grass pollen-specific Total Nasal Symptom Score (TNSS) of grass pollen-induced allergic rhinitis provoked by spending 6 hours in the VCC before the treatment, and at Visit 9. • effect of treatment with different dosing schedules of BM32 on the Symptom-Scores (SS), Medication-Scores (MS) and Combined Symptom/Medication Scores (SMS) recorded in the Patient Diary during the peak of the grass pollen season. • Effect of treatment with BM32 dosing schedules on the “Well-being” of subjects during the grass pollen season as measured via a visual analogue score (VAS) recorded in the Patient Diary. • Development of immunological parameters during the study by measuring grass pollen allergen-specific IgG, IgG1, IgG4 in serum samples collected from subjects at different time points. • Relative safety and tolerability of the different BM32 dosing schedules vs. placebo. ;Primary end point(s): • Level of allergen-specific IgG4 antibodies at the peak of the grass pollen season (Visit 8) comparing the sum of IgG levels against Phl p 1 + Phl p 5 of each BM32 group vs. placebo. • Level of allergen-specific IgG1 antibodies at the peak of the grass pollen season (Visit 8) comparing the sum of IgG levels against Phl p 1 + Phl p 5 of each BM32 group vs. placebo. ;Timepoint(s) of evaluation of this end point: Visit 3 (baseline levels, before treatment) Visit 8 (at the peak of the grass pollen season);Main Objective: To assess the level of allergen-specific IgG4 and IgG1 antibodies at the peak of the grass pollen season comparing the different dosing schedules of BM32 at the dose of 20µg per API with placebo. ;Secondary Objective: • effec | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Difference in the total Nasal Symptom Score (TNSS) (nasal obstruction, rhinorrhea, itchy nose and sneezing) between spending 6 hours in the VCC at Visit 2 and spending 6 hours in the VCC at Visit 9. • The mean daily Symptom-Score (SS), Medication-Score (MS), and Combined Symptom-/ Medication Score (SMS) measured during the grass pollen season and the peak of the grass pollen season. • Mean level of “well-being” during the grass pollen season of patients receiving BM32 compared to placebo based on daily records on a visual analogue score (VAS) • Mean allergen-specific antibodies (IgG. IgG1, IgG4) as measured at different time points during the study (Visits 1,3,4,5,6,7,8, 9, 10, and 11) compared between verum treated and placebo treated patients. • Frequency of AEs concerning occurrence, seriousness, intensity and relationship to study drug. • Frequency and grading of SIT-specific local and systemic reactions. • Lung function (FEV1), blood pressure, pulse rate, body temperature, and breathing frequency at screening, and throughout the study • Findings of physical examination at screening, and at the follow-up Visit ;Timepoint(s) of evaluation of this end point: Efficacy endpoints will be evaluated during the peak of the grass pollen season or after the grass pollen season (visit 9) respectively. Immunogenicity endpoints and safety endpoints will be evaluated throughout the study.;Secondary end point(s): • Difference in the total Nasal Symptom Score (TNSS) (nasal obstruction, rhinorrhea, itchy nose and sneezing) between spending 6 hours in the VCC at Visit 2 and spending 6 hours in the VCC at Visit 9. • The mean daily Symptom-Score (SS), Medication-Score (MS), and Combined Symptom-/ Medication Score (SMS) measured during the grass pollen season and the peak of the grass pollen season. • Mean level of “well-being” during the grass pollen season of patients receiving BM32 compared to placebo based on daily records on a visual analogue score ( | — |
Countries
Austria
Contacts
Public ContactProduct Development Department;Product Development Department;Product Development Department ;;
Biomay AG;Biomay AG;Biomay AG
Outcome results
None listed