Phase IIb study on the safety and efficacy of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy
- Conditions
- grass pollen allergy10001708
- Registration Number
- NL-OMON39223
- Lead Sponsor
- Biomay AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
*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 or within 12 months prior to the screening visit.
* Moderate to severe symptoms of grass pollen allergy during pollen
peak in the screening period (exact definition of this criterion is
specified in the study reference manual (SRM))
* Age between 18 and 60 years (m/f)
* Subjects must have a standard health care insurance
* Subject must appear capable to understand and comply
with all relevant aspects of the study protocol
* Subject must be available during the study period to
complete all treatments and assessments
* symptomatic perennial allergies or symptomatic seasonal co-allergies during the grass pollen season
* atopic dermatitis
* pregnancy or breast feeding
* women with childbearing potential who are not using a medically
accepted birth control method
* autoimmune diseases, immune defects including immunosuppression,
immune-complex-induced immunopathies
* contra-indication for adrenaline
* severe general maladies, malignant diseases
* patients under long-term treatment with systemic corticosteroids,
* contra-indications for skin prick testing such as: skin inflammation
in the test area, urticaria facticia.
* bronchial asthma not controlled by low dose inhaled corticosteroids This means that Patients with a history of concomitant asthma should have a FEV1 > 70% at inclusion. Patients without a history of asthma should have FEV1 >70% or a PEF > 80% at inclusion
* chronic use of beta-blockers
* participation in another clinical trial within one month prior to the
study; however, participation during the previous month solely in
the form of blood donation and/or without other interventions will be
acceptable
* patients who participated in a pollen SIT trial or received marketed pollen SIT in 2 years prior to study
* patients who had a previous grass pollen SIT or have participated in a clinical trial of grass pollen SIT
* risk of non-compliance with the study procedure and restrictions (e.g. with alcohol, drug or medication abuse within the past year)
* Use of prohibited medication prior to Screening (Visit 1) and
throughout the study:
- Depot corticosteroids - 12 weeks prior to Visit 1
- Oral corticosteroids - 8 weeks prior to V1
- High -dose inhaled corticosteroids - 4 weeks prior to V1
* Use of anti-histamines three days prior to V1 or V2
* Patients with nasal polyposis
* Patients sensitized to Phl p 7
(specific IgE to Phl p 7 and/or Bet v 4 > 0,35 kUA/L)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints will be:<br /><br>• The mean daily combined Symptom-Medication-Score (SMS)<br /><br>during the grass pollen peak of treatment year 1. The mean<br /><br>daily combined SMS will be compared between the treatment group and placebo.<br /><br>• The mean daily combined Symptom-Medication-Score (SMS)<br /><br>during the grass pollen peak of treatment year 2. The mean<br /><br>daily combined SMS will be compared between the treatment groups and placebo.<br /><br>Co-primary Safety Endpoints<br /><br>• Frequency of AEs concerning occurrence, seriousness,<br /><br>intensity and relationship to study drug.<br /><br>• Frequency and grading of local and systemic reactions.<br /><br>• Vital functions and findings of physical examination<br /><br>• Safety Laboratory (Hematology, blood biochemistry, and urine<br /><br>analysis)</p><br>
- Secondary Outcome Measures
Name Time Method