Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005543

Trial Description

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Title

Phase IIb Study on the Safety and Efficacy of BM32, a Recombinant Hypoallergenic Vaccine for Immunotherapy of Grass Pollen Allergy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005543
  •   2014/08/22
  •   2012/02/07
  •   no
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Secondary IDs

  •   2012-000442-35 
  •   NCT01538979  (ClinicalTrials.gov)
  •   CS-BM32-003  (Biomay AG)
  •   2012-000442-35 
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Health Condition or Problem studied

  •   Grass Pollen Allergy
  •   J30.1 -  Allergic rhinitis due to pollen
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Interventions/Observational Groups

  •   Biological: BM32
  •   Biological: BM32
  •   Biological: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Mean daily combined symptom medication score (SMS)during the peak of the pollen season.; time frame: Up to 3 months; The score will be recorded daily for the 30-45 days with the highest pollen count in each center

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Secondary Outcome

- Vital functions; time frame: Up to 22 months
- Safety laboratory hematology; time frame: up to 22 months
- Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season; time frame: Up to 8 months; 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; 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; 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; 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; 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; 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; 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; 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; 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
- Safety Laboratory: Blood biochemistry; time frame: Up to 22 months
- Safety laboratory: Urine analysis; time frame: up to 22 months

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   Denmark
  •   Germany
  •   Netherlands
  •   Slovenia
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Locations of Recruitment

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Recruitment

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  •   2012/03/31
  •   180
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional 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

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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

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Addresses

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    • Biomay AG
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    • Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie
    • Johannes Ring, Prof. Dr. Dr. 
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    • Angela Neubauer, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.