EUCTR2015-004551-43-AT进行中（未招募）1 期
Study to evaluate the effect of different pre-seasonal BM32 dosing schedules on the induction of a protective allergen-specific IgG Immune response
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biomay AG
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
- •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:
- 另有 4 项未显示
排除标准
- •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:
- •oDepot corticosteroids – 12 weeks prior to Visit 1
- •oOral corticosteroids – 8 weeks prior to Visit 1
- •olong-acting inhaled corticosteroids – 4 weeks
- •prior to Visit 1
- •odepot corticosteroids or long-acting inhaled corticosteroids throughout the study
- •oanti-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
- •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:
- •oDepot corticosteroids – 12 weeks prior to Visit 1
- •oOral corticosteroids – 8 weeks prior to Visit 1
- •olong-acting inhaled corticosteroids – 4 weeks
- •prior to Visit 1
- •odepot corticosteroids or long-acting inhaled corticosteroids throughout the study
- •oanti-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
- •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:
- •oDepot corticosteroids – 12 weeks prior to Visit 1
- 另有 7 项未显示
研究者
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