NCT01451450撤回2 期
A Phase II, Randomized, Double Blind, Placebo-controlled, Parallel Design, Dose Ranging, Multi-center Trial of Four Levels of Exposure of QGE031 s.c. for 16 Weeks in Subjects Aged 18-50 Years of Age With Peanut Allergy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
研究概览
简要总结
This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours).
- •Positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test.
排除标准
- •Prior exposure to any monoclonal antibody treatment
- •Asthma patients on maintenance long acting beta-agonists
- •Use of systemic corticosteroids
- •Concomitant use of beta blockers, ACE inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists
- •Use of immunosuppressants within 6 months of visit 1 Other protocol-defined inclusion/exclusion criteria may appy
研究组 & 干预措施
QGE031 A
Experimental
干预措施: QGE031 (Drug)
QGE031 B
Experimental
干预措施: QGE031 (Drug)
QGE031 C
Experimental
干预措施: QGE031 (Drug)
QGE031 D
Experimental
干预措施: QGE031 (Drug)
Placebo A
Placebo Comparator
干预措施: Placebo (Drug)
Placebo B
Placebo Comparator
干预措施: Placebo (Drug)
Placebo C
Placebo Comparator
干预措施: Placebo (Drug)
Placebo D
Placebo Comparator
干预措施: Placebo (Drug)
研究者
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