A 52 week, multi-center, randomized, double-blind placebocontrolled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy - Efficacy and safety of QGE031 (ligelizumab) in patients with peanut allergy

Hiroyuki Yamada0 个研究点目标入组 18 人开始时间: 2021年12月26日最近更新: 2023年10月17日

研究概览

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•1. Male or female participants who are >= 6 and =< 55 years of age at the time of signing informed consent/assent.
•2. Documented medical history of allergy to peanuts or peanut-containing foods.
•3. Positive peanut-specific immunoglobulin E (peanut sIgE), >= 6 kUA/L at Screening visit 1 (Screening 1).
•4. 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.
•5. 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, and no occurrence on placebo. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
•6. Participants must weigh >= 20 kg at Screening 1.

•1. Total IgE >2000 IU/mL at Screening 1.
•2. History of severe or life-threatening hypersensitivity event needing an ICU admission or intubation within 60 days prior to baseline DBPCFC (Screening visit 2).
•3. 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

发起方

Hiroyuki Yamada