HypersensitivityPhase 2NCT02643641
Effect of Different Pre-seasonal BM32 Dosings on the Induction of a Protective Immune Response
A Phase 2 study testing BM32 in people with Hypersensitivity, run by Biomay AG at 1 site in Austria.
Trial summary
BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This prospective, double-blind. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- BM32
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2016to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 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 with a wheal diameter >5mm for grass pollen extract at the screening visit.
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- They have a positive serum IgE test for timothy grass pollen and to rPhl p 1+rPhl p 5 at the screening visit (ImmunoCAP ≥3.5 kUA/l; i.e ≥ class 2)..
- 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
Who cannot join
- Sensitization to Phl p 7
- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Effect of Different Pre-seasonal BM32 Dosing Schedules on the Rapid Induction of a Protective IgG Immune Response
BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the grass pollen season.
Read the detailed description
The aim of this study is to further optimize the immunization schedule by
- moving the last injection into beginning of the grass pollen season for all study arms in order to ensure highest possible IgG4 levels when they are needed - i.e. at the peak of the grass pollen season,
- administration of more than 3 pre-seasonal injections in order to build up sufficiently high levels of IgG4 already in the first year of treatment , and
- dosing during the beginning of the grass pollen season to establish safety in this setting The effect of such optimized immunization schedule on the induction of an IgG4 immune response as a surrogate parameter for efficacy will be studied. The Total Nasal Symptom Score (TNSS) before and after the treatment and Combined Symptom-Medication Score (SMS) during the grass pollen season will be evaluated as secondary endpoints. This will allow intra-individual comparison of seasonal symptom data and responsiveness in the chamber setting.
- Conditions
- Hypersensitivity
- Being tested
- BM32, Placebo
- Keywords
- Grass pollen allergy, subcutaneous immunotherapy, allergy vaccine, dose regimen
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM32Biological
BM32 is a mixture of 4 different recombinant proteins directed at the major grass pollen allergens, adsorbed on aluminum hydroxide
PlaceboBiological
Placebo contains aluminum hydroxide only
| Study group | Role | What they receive |
|---|---|---|
| BM32-3 | Experimental | 2 placebo injections will be given followed by 3 injections with 20 micrograms each of BM321, BM322, BM325 and BM326 Receives: Biological: BM32 |
| BM32-4 | Experimental | 1 placebo injections will be given followed by 4 injections with 20 micrograms each of BM321, BM322, BM325 and BM326 Receives: Biological: BM32 |
| BM32-5 | Experimental | 5 injections with 20 micrograms each of BM321, BM322, BM325 and BM326 will be given Receives: Biological: BM32 |
| Placebo | Placebo comparator | 5 placebo injections (alhydrogel only) will be given Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titer of allergen specific IgG4 antibodies
Measured: approximately 6 months
Secondary outcomes (4)
Total nasal symptom score upon pollen challenge (TNSS)
Sensitivity to a grass pollen challenge in an environmental exposure chamber
Measured: Change from baseline at 9 months
Mean daily combined symptom and medication score (SMS)
Measured: 2 weeks
Well-being via visual analog scale
Measured: 2 weeks
Titers of allergen specific IgG antibodies
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomay AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petra Zieglmayer, MD, Principal investigator, Vienna Challenge Chamber GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643641
- Sponsor's protocol ID
- CS-BM32-004
- Status last verified
- Jan 2017
- First submitted
- 17 Dec 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Effect of Different Pre-seasonal BM32 Dosing Schedules on the Rapid Induction of a Protective IgG Immune Response
- ClinicalTrials.gov ID
- NCT02643641
- Acronym / sponsor ID
- CS-BM32-004
- Conditions
- Hypersensitivity
- Keywords
- Grass pollen allergy, subcutaneous immunotherapy, allergy vaccine, dose regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Biomay AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the grass pollen season.
Detailed description
The aim of this study is to further optimize the immunization schedule by
- moving the last injection into beginning of the grass pollen season for all study arms in order to ensure highest possible IgG4 levels when they are needed - i.e. at the peak of the grass pollen season,
- administration of more than 3 pre-seasonal injections in order to build up sufficiently high levels of IgG4 already in the first year of treatment , and
- dosing during the beginning of the grass pollen season to establish safety in this setting The effect of such optimized immunization schedule on the induction of an IgG4 immune response as a surrogate parameter for efficacy will be studied. The Total Nasal Symptom Score (TNSS) before and after the treatment and Combined Symptom-Medication Score (SMS) during the grass pollen season will be evaluated as secondary endpoints. This will allow intra-individual comparison of seasonal symptom data and responsiveness in the chamber setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BM32-3 | Experimental | Biological: BM322 placebo injections will be given followed by 3 injections with 20 micrograms each of BM321, BM322, BM325 and BM326 |
| BM32-4 | Experimental | Biological: BM321 placebo injections will be given followed by 4 injections with 20 micrograms each of BM321, BM322, BM325 and BM326 |
| BM32-5 | Experimental | Biological: BM325 injections with 20 micrograms each of BM321, BM322, BM325 and BM326 will be given |
| Placebo | Placebo comparator | Biological: Placebo5 placebo injections (alhydrogel only) will be given |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 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).
Key exclusion criteria (7 listed)
- Sensitization to Phl p 7
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BM32BM32 is a mixture of 4 different recombinant proteins directed at the major grass pollen allergens, adsorbed on aluminum hydroxide | Biological | BM32-3, BM32-4, BM32-5 |
| PlaceboPlacebo contains aluminum hydroxide only | Biological | Placebo |
Primary outcome
Titer of allergen specific IgG4 antibodies
Time frame: approximately 6 months
4 secondary outcomes
Total nasal symptom score upon pollen challenge (TNSS)
Time frame: Change from baseline at 9 months
Mean daily combined symptom and medication score (SMS)
Time frame: 2 weeks
Well-being via visual analog scale
Time frame: 2 weeks
Titers of allergen specific IgG antibodies
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Zieglmayer, MD principal investigator
Vienna Challenge Chamber GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BM32 in people with Hypersensitivity, run by Biomay AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titer of allergen specific IgG4 antibodies (time frame: approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.