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

ovartis Pharma AG0 个研究点目标入组 486 人开始时间: 2021年10月15日最近更新: 2022年5月30日

适应症

试验速览

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•- 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), = 6 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, and no occurrence on placebo. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
•- Participants must weigh = 20 kg at Screening 1.
•Other protocol-defined inclusion criteria may apply.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 324
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 162
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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 visit 2).
•- 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
•Other protocol-defined exclusion criteria may apply.

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