NL-OMON39223已完成2 期
Phase IIb study on the safety and efficacy of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy - CS-BM32-003
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biomay AG
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*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
排除标准
- •* 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
- •* 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)
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