Clinical Trial Results:
The effect of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy, on immunoglobulin levels in nasal secretions of patients suffering from seasonal allergic rhinitis
Summary
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EudraCT number |
2012-004194-12 |
Trial protocol |
AT |
Global end of trial date |
21 Nov 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Nov 2020
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First version publication date |
04 Nov 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CS-BM32-nasal-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Währinger Gürtel 18-20, Vienn, Austria, 1090
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Public contact |
HNO Klinik, Medizinische Universität Wien, +43 1404003438, verena.niederberger@meduniwien.ac.at
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Scientific contact |
HNO Klinik, Medizinische Universität Wien, +43 1404003438, verena.niederberger@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Interim
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Date of interim/final analysis |
15 Oct 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Nov 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Nov 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo, on allergen-specific Ig levels in nasal secretion during 2 consecutive treatment years.
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Protection of trial subjects |
patients were attending the outpatient department for their visits and could contact the primary investigator or the department any time
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Dec 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 38
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Worldwide total number of subjects |
38
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EEA total number of subjects |
38
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
38
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients participating in the study CS-BM32-003 (EK 1104/2012) were be recruited by personal contact. | |||||||||||||||
Pre-assignment
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Screening details |
Inclusion criteria: • Positive history of grass pollen allergy, positive skin prick test reaction to grass pollen extract, grass pollen allergen-specific IgE and rPhl p 1/rPhl p 5-specific IgE (at least 3.5 kUA/L) at the screening visit of CS-BM32-003 or within 12 months prior to the screening visit of CS-BM32-003 | |||||||||||||||
Period 1
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Period 1 title |
Main study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer | |||||||||||||||
Blinding implementation details |
Blinding was performed in main study
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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BM32 | |||||||||||||||
Arm description |
BM32 | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
BM32
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
s.c.
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Arm title
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Placebo | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
s.c.
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Baseline characteristics reporting groups
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Reporting group title |
BM32
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Reporting group description |
BM32 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
BM32
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Reporting group description |
BM32 | ||
Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
Ig levels in nasal secretions [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Treatment year one:
• Visit 1: before the 1st pre-seasonal vaccination
• Visit 2: after the 3rd pre-seasonal vaccination
• Visit 3: in the middle of the grasspollen season
• Visit 4: 2 weeks after the end of the grass pollen sea
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistic |
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Notes [2] - no statistic [3] - no statistic |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events are divided into the categories “serious” and “non-serious”. This determines the procedure which must be used to report/document the adverse event
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
n.a.
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Frequency threshold for reporting non-serious adverse events: 2% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: no adverse events |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |