EUCTR2012-000442-35-DK进行中（未招募）1 期
PHASE II STUDY ON THE SAFETY AND EFFICACY OF BM32, A RECOMBINANT HYPOALLERGENIC VACCINE FOR IMMUNOTHERAPY OF GRASS POLLEN ALLERGY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biomay AG
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In(1).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 at the screening visit or within 12 months prior to the screening visit.
- •In(2).Moderate to severe symptoms of grass pollen allergy during pollen peak in the baseline period (exact definition of this criterion is specified in the study reference manual (SRM))
- •In(3).Age between 18 and 60 years (m/f)
- •In(4).Subjects must have a standard health care insurance
- •In(5).Subject must appear capable to understand and comply with all relevant aspects of the study protocol
- •In(6).Subject must be available during the study period to complete all treatments and assessments
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Ex(1).symptomatic perennial allergies or symptomatic seasonal coallergies
- •Ex(2).atopic dermatitis
- •Ex(3).pregnancy or breast feeding
- •Ex(4).women with childbearing potential who are not using a medically accepted birth control method
- •Ex(5).autoimmune diseases, immune defects including immuno- suppression, immune-complex-induced immunopathies
- •Ex(6).contra-indication for adrenaline
- •Ex(7).severe general maladies, malignant diseases
- •Ex(8).patients under long-term treatment with systemic corticosteroids, immuno-suppressive drugs, tranquilizers or psychoactive drugs
- •Ex(9).contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria facticia.
- •Ex(10).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
- •Ex(11).Chronic use of beta-blockers
- •Ex(12).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
- •Ex(13).patients who participated in a pollen SIT trial or received marketed pollen SIT in 2 years prior to study
- •Ex(14).patients who had a previous grass pollen SIT or have participated in a clinical trial of grass pollen SIT
- •Ex(15).risk of non-compliance with the study procedure and restrictions (e.g. with alcohol, drug or medication abuse within the past year)
- •Ex(16).Use of prohibited medication prior to Screening (Visit 1) and throughout the study:
- •o Depot corticosteroids – 12 weeks prior to V1
- •o Oral corticosteroids – 8 weeks prior to V1
- •o High –dose inhaled corticosteroids – 4 weeks prior to V1
- •Ex(17).Use of anti-histamines three days prior to V1 or V2
- •Ex(18). patients with nasal polyposis
- •Ex(19). patients sensitized to Phl p 7 (specific IgE to Phl p 7 and/or Bet v 4 > 0,35 kUA/L)
研究者
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