Grass pollen allergy
Conditions
Interventions
Product Name: BM32 (4 API components)
Product Code: BM32/S1
Pharmaceutical Form: Suspension for injection
Current Sponsor code: BM321
Other descriptive name: BM321
Concentration unit: µg/ml microgram(
Sponsors
Biomay AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? The subject is 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 deemed by the Investigator or designee. ? Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent. They have a history of seasonal allergic rhinitis (SAR) to grass pollen. ? They have a normal electrocardiogram without clinically significant abnormalities deemed by the Investigator or designee. ? They exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 after the first 2h 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, rhinorrhoea, itchy nose and sneezing, each of which have been Scored on a scale from 0 to 3). ? They have a positive skin prick test (wheal diameter ? 3mm) for grass pollen at or within 12 months preceding the screening visit. ? They have a positive RAST (class greater/equal 2) for timothy grass pollen (g6) and to rPhl p 1+rPhl p 5 at or within 12 months preceding the screening visit. ? 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 72 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). ? 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 and associated with normal lung function. ? The subject is concurrently participating or has participated in any clinical study in the previous month. ? The subject has received SIT for grass pollen allergy in the last two years prior to this study. ? Past or present disease, which as judged by the investigator, may affect the outcome of this study. ? autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies ? Suspected hypersensitivity to any ingredients of the study medication ? Use of prohibited medication prior to Screening and throughout the study: o Depot corticosteroids – 12 weeks o Oral corticosteroids – 8 weeks o Inhaled corticosteroids – 4 weeks ? The subject is at risk of non-compliance with the study procedures/restrictions. ? Allergic symptoms at the time of screening ? Any other reason that the Investigator considers makes the subject unsuitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the relative safety and tolerability of three different dose levels of BM32 compared to placebo. •To assess the minimum effective dose after three subcutaneous injections of different dose levels of BM32 as compared to placebo. The effects of different dose levels of BM32 compared to placebo are evaluated by the grass pollen-specific Total Nasal Symptom Score (TNSS – nasal obstruction, rhinorrhoea, itchy nose and sneezing) of grass pollen-induced allergic rhinitis provoked by spending 6h in the VCC at screening and 6h in the VCC after the last injection (Visit 8) of the treatment;Secondary Objective: -To determine the effects of vaccination with BM32 versus placebo on allergen-specific antibody responses and on allergy related immunological parameters - To evaluate the effects of different dose levels of BM32 compared to placebo by grass pollen spec. TNNSS, (TOSS & OSS) and by evaluating the Global Symptom Score (Total Nasal Symptom Score (TNSS) and Total Non-Nasal Symptom Score (TNNSS) combined) of provoked grass pollen-induced allergic rhinitis - To determine the effects of vaccination with BM32 versus placebo on allergen-specific skin responses by titrated skin prick testing (SPT) -To evaluate the effects of different dose levels of BM32 compared to placebo by the mean cross-sectional area (MCA) using anterior rhinomanometry (NAR) -To evaluate the effects of different dose levels of BM32 compared to placebo by FEV1 and FEV1/FVC ;Primary end point(s): •Difference in the total Nasal Symptom Score (TNSS) (nasal obstruction, rhinorrhoea, itchy nose and sneezing) between spending 6h in the VCC at screening and spending 6h in the VCC 4 weeks after the last injection of the treatment (Visit 8). •Frequency of AEs concerning occurrence, seriousness, intensity and drug-relationship. •Frequency of local reactions (injection site reactions) and systemic reactions classified by a grading scheme according to the Position Paper of the German Socie | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Difference in the Total Non-Nasal Symptom Score TNNSS (TOSS and OSS) between the 6h spent in the VCC at screening and the 0-6h period spent in the VCC 4 weeks after the last injection of the treatment (Visit 8). •Difference in the Global Symptom Score (TNSS and TNNSS) between the 6h spent in the VCC at screening and the 0-6h period spent in the VCC 4 weeks after the last injection of the treatment (Visit 8). • Difference in the nasal airflow resistance (NAR) (measured using active anterior rhinomanometry) between the 6h spent in the VCC at screening and the 0-6h period spent in the VCC 4 weeks after the last injection of the treatment (Visit 8). •Change in skin reaction to grass pollen allergens (SPT) before (screening) and after the treatment (visit 7) by dose titration of the grass pollen extract measuring the difference in the sum of wheal areas between these two visits and evaluating the change in the threshold concentration of grass pollen extract necessary to provoke a positive skin reaction (SPT) •Difference in the FEV1 and FEV1/FVC between Screening and Visit 8 •Administration of rescue medication via total amount of rescue medication needed •Vital signs and physical examination • Laboratory : haematology, biochemistry, and urinalysis at screening, medication phase and at the follow-up examination. Immunogenicity: •Change in allergen specific total IgG levels after 3 s.c. injection with BM32, as measured at screening and visit 7 •Change in allergen specific IgE levels after 3 s.c. injection with BM32, as measured at screening and visit 7 •Change in allergy related immunological parameters (T-cell responses and cytokine responses to recombinant allergens, grass pollen extract, BM32 components, and the carrier (PreS), as well as the sensitivity to recombinant grass pollen allergens and timothy grass pollen extract in allergen-induced basophile activation and in the CD203c assay) levels after 3 s.c. injection with BM32, as measured in b | — |
Countries
Austria
Outcome results
None listed