NL-OMON52165已完成3 期
A 52 week, multi-center, randomized, double-blind placebo-controlled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy - CQGE031G12301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 14
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
- 2 至 64（—）
入选标准
- •- Male or female participants who are >= 6 and <= 55 years of age at the time of
- •signing informed consent/assent.
- •- Documented medical history of allergy to peanuts or peanut-containing foods.
- •- Positive peanut-specific immunoglobulin E (peanut sIgE), >= 3.5 kUA/L at
- •Screening visit 1 (Screening 1)
- •- Positive skin prick test (SPT) for peanut allergen at Screening 1 defined as
- •an average diameter (Longest diameter and mid-point orthogonal diameter) >= 4 mm
- •wheal compared to saline control.
- •- A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2
- •DBPCFC) defined as the occurrence of dose-limiting symptoms at a single dose <=
- •100 mg of peanut protein.
- •Eligibility to proceed with the DBPCFC requires fulfillment of all other
- •eligibility criteria.
- •- Participants must weigh >= 20 kg at Screening 1.
排除标准
- •- Total IgE >2000 IU/mL at Screening 1.
- •- History of severe or life-threatening hypersensitivity event needing an ICU
- •admission or intubation within 60 days prior to baseline DBPCFC (Screening
- •- Participants with uncontrolled asthma (according to GINA guidelines, GINA
- •2020) who meet any of the following criteria:
- •- FEV1 <80% of subject's predicted normal value at Screening visit 1
- •- One hospitalization for asthma within 12 months prior to Screening visit 1
研究者
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