Trial record 1 of 19 for:
Open Studies | "Rhinitis, Allergic, Seasonal"
Phase II Study of Grass Pollen Allergy Vaccine BM32
This study is currently recruiting participants.
Verified January 2013 by Biomay AG
Sponsor:
Biomay AG
Information provided by (Responsible Party):
Biomay AG
ClinicalTrials.gov Identifier:
NCT01538979
First received: February 7, 2012
Last updated: January 10, 2013
Last verified: January 2013
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Purpose
The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off allergy symptoms over a two year study period.
| Condition | Intervention | Phase |
|---|---|---|
|
Grass Pollen Allergy |
Biological: BM32 Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase IIb Study on the Safety and Efficacy of BM32, a Recombinant Hypoallergenic Vaccine for Immunotherapy of Grass Pollen Allergy |
Resource links provided by NLM:
Further study details as provided by Biomay AG:
Primary Outcome Measures:
- Mean daily combined symptom medication score (SMS)during the peak of the pollen season. [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]The score will be recorded daily for the 30-45 days with the highest pollen count in each center
Secondary Outcome Measures:
- Vital functions [ Time Frame: Up to 22 months ] [ Designated as safety issue: Yes ]
- Safety laboratory hematology [ Time Frame: up to 22 months ] [ Designated as safety issue: Yes ]
- Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: Yes ]The VAS will be recorded daily during the grass pollen seasons of 2013 and 2014
- Number of "bad days" during the peak pollen season and the whole pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]The number of bad days will be recorded daily during the grass pollen seasons of 2013 and 2014
- Number of symptom-free days during the peak pollen season and the whole pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]The mesure will be recorded daily during the grass pollen seasons of 2013 and 2014
- Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season [ Time Frame: Approx. 22 months ] [ Designated as safety issue: No ]The questionnaire will be completed on a weekly basis during the pollen seasons of 2013 and 2014.
- Mean asthma score during pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]The score will be recorded on a daily basis duirng the pollen seasons of 2013 and 2014
- Mean allergy specific IgG and IgE antibodies before and after vaccination [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]These antibody levels will be recorded a total of five times (01/2013, 04/2013, 09/2013, 01/2014 and 04/2014)
- Mean daily symptom and medication score during the whole pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]The score will be recorded daily approximately during May 2013 - August 2013 and May 2014 - August 2014
- Mean daily symptom score (SS) and medication score (MS) during the peak pollen season and the whole pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]The scores will be recorded daily during the pollen seasons of 2013 and 2014
- Skin reactivity to grass pollen extract by titrated skin prick testing [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]The titrated skin prick testing will be applied a total of 4 times before and after the pollen seasons of 2013 and 2014.
- Results of physical examination [ Time Frame: up to 22 months ] [ Designated as safety issue: Yes ]
- Safety Laboratory: Blood biochemistry [ Time Frame: Up to 22 months ] [ Designated as safety issue: Yes ]
- Safety laboratory: Urine analysis [ Time Frame: up to 22 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BM32 low dose
7 subcutaneous injections of 20 micrograms over two grass pollen seasons
|
Biological: BM32
Subcutaneous injection of 20 micrograms of each of the protein components of BM32 adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season
|
|
Experimental: BM32 high dose
7 subcutaneous injections of 40 micrograms over two grass pollen seasons
|
Biological: BM32
Subcutaneous injection of 40 micrograms of each of the protein components of BM32 adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season
|
|
Placebo Comparator: Placebo
7 subcutaneous injections over a time span of two pollen seasons
|
Biological: Placebo
Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every four weeks before each pollen season and one injection after pollen season for a total of 7 injections
|
Detailed Description:
The present study is designed to evaluate the efficacy and safety of a treatment with the recombinant vaccine BM32 during two consecutive grass pollen seasons. Efficacy evaluation will be performed on the basis of allergy symptoms and use of relief medication as well as based on immunological parameters. After patient assessment during a screening season, patients will be randomized to one of two doses of BM32 or placebo. Patients will receive three injections of BM32 pre-season and one post-season boost injection to maintain optimal allergen specific IgG responses. Outcome will be measured after both seasons individually.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Positive history of grass pollen allergy
- Positive skin prick test reaction to grass pollen extract
- Grass pollen specific IgE and rPhl p 1/rPhl p 5 specific IgE (>3 kUA/L)
- Moderate to severe symptoms of grass pollen allergy during pollen peak
Exclusion Criteria:
- Symptomatic perennial allergies
- Atopic dermatitis
- Pregnancy or breast feeding
- Women with childbearing potential not using medically accepted birth control
- Autoimmune diseases, immune defects, immune suppression
- Immune complex induced immunopathies
- Contra indications for adrenaline
- Severe general maladies, malignancies
- Patients on long-term systematic corticosteroids, immune suppressive drugs, tranquilizers or psychoactive drugs
- Contra indication for skin prick testing
- Bronchial asthma not controlled by low dose inhaled corticosteroids
- Chronic use of beta blockers
- Participation in another clinical trial within one month prior to study
- Participation in SIT trial in 2 years prio to study
- Patients who had a previous grass pollen SIT
- Risk of non-compliance with study procedures
Use of prohibited medications
- Depot corticosteroids - 12 weeks prior to enrolment
- Oral corticosteroids - 8 weeks prior to enrolment
- High dose inhaled corticosteroids - 4 weeks prior to enrolment
- Use of H1 antihistamines 3 days prior to enrolment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538979
Contacts
| Contact: Angela Neubauer, PhD | +43-1-7966-296 ext 101 | a.neubauer@biomay.com |
| Contact: Nora Breit | +43-1-7966-296 ext 115 | n.breit@biomay.com |
Locations
| Austria | |
| Universitätsklinik für Dermatologie und Allergologie | Recruiting |
| Graz, Austria, 8036 | |
| Contact: Werner Aberer, Prof. Dr. +43-316-385-12371 werner.aberer@medunigraz.ac.at | |
| Principal Investigator: Werner Aberer, Prof. Dr. | |
| Medical University | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Verena Niederberger-Leppin, MD +43-1-40400 verena.niederberger@meduniwien.ac.at | |
| Principal Investigator: Verena Niederberger-Leppin, MD | |
| Belgium | |
| Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Philippe Gevaert, Prof. Dr. +32-9332-4993 | |
| Principal Investigator: Philippe Gevaert, Prof. Dr. | |
| Denmark | |
| Allergy Clinic Copenhagen University Hospital at Gentofte | Recruiting |
| Hellerup, Denmark | |
| Contact: Hans-Jorgen Malling, Prof. Dr. +45-3977-2489 HMAL0009@geh.regionh.dk | |
| Principal Investigator: Hans-Jorgen Malling, Prof. Dr. | |
| Germany | |
| Department of Dermatology and Allergology Am Biederstein TU Munich | Recruiting |
| Munich, Bavaria, Germany, 80802 | |
| Contact: Johannes Ring, Prof. Dr. Dr. +49-89-4140-3171 johannes.ring@lrz.tu-muenchen-de | |
| Principal Investigator: Johannes Ring, Prof. Dr. Dr. | |
| Allergiezentrum Charite | Recruiting |
| Berlin, Germany, 10117 | |
| Contact: Margitta Worm, Prof. Dr. +49-30-450-518105 margitta.worm@charite.de | |
| Principal Investigator: Margitta Worm, Prof. Dr. | |
| Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn | Recruiting |
| Bonn, Germany, 53105 | |
| Contact: Natalija Novak, Prof. Dr. +49-228-287-15370 natalija.novak@ukb.uni-bonn.de | |
| Principal Investigator: Natalija Novak, Prof. Dr. | |
| Dept. of Dermatology and Allergology University Medical Center Gieseen and Mrbaurg GmbH | Recruiting |
| Marburg, Germany, 35043 | |
| Contact: Wolfgang Pfützner, PD Dr. +49-6421-58-66474 wpfuetzn@med.uni-marburg.de | |
| Principal Investigator: Wolfgang Pfützner, PD DR. | |
| Zentrum für Rhinologie/Allergologie | Recruiting |
| Wiesbaden, Germany, 65183 | |
| Contact: Oliver Pfaar, Prof. Dr. +49-611-308-6080 oliver.pfaar@allergiezentrum.org | |
| Principal Investigator: Ludger Klimek, Prof. Dr. | |
| Netherlands | |
| Dept. of Internal Medicine Erasmus Medical Center | Recruiting |
| Rotterdam, Netherlands, 3105 | |
| Contact: Roy Gert van Wijk, Prof. Dr. r.gerthvanwijk@erasmusnc.nl | |
| Principal Investigator: Roy Gert van Wijk, Prof. Dr. | |
| Slovenia | |
| University Clinic of Respiratory and Allergic Diseases Golnik | Recruiting |
| Golnik, Slovenia, 4204 | |
| Contact: Mitja Kosnik, Prof. Dr. mitja.kosnik@klinika-golnik.si | |
| Principal Investigator: Mitja Kosnik, Prof. Dr. | |
Sponsors and Collaborators
Biomay AG
Investigators
| Study Chair: | Johannes Ring, Prof. Dr. Dr. | Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie |
More Information
No publications provided
| Responsible Party: | Biomay AG |
| ClinicalTrials.gov Identifier: | NCT01538979 History of Changes |
| Other Study ID Numbers: | CS-BM32-003, 2012-000442-35 |
| Study First Received: | February 7, 2012 |
| Last Updated: | January 10, 2013 |
| Health Authority: | Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products Denmark: Danish Medicines Agency Germany: Paul-Ehrlich-Institut Netherlands: Medicines Evaluation Board (MEB) Slovenia: Agency for Medicinal Products - Ministry of Health |
Keywords provided by Biomay AG:
|
Grass pollen allergy Immunotherapy Recombinant vaccine Rhinitis, allergic, seasonal |
Additional relevant MeSH terms:
|
Hypersensitivity Rhinitis, Allergic, Seasonal Immune System Diseases Rhinitis Nose Diseases |
Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on May 16, 2013