Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
Allergy, Peanut
About this trial
This is an interventional treatment trial for Allergy, Peanut focused on measuring Food allergy, Peanut allergy, Oral food challenge, IgE, ligelizumab
Eligibility Criteria
Inclusion Criteria:
- 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), ≥ 0.35 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.
Exclusion Criteria:
- 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 inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
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- Novartis Investigative SiteRecruiting
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- Novartis Investigative SiteRecruiting
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- Novartis Investigative Site
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
ligelizumab 240 mg
ligelizumab 120 mg
Placebo 8 weeks and ligelizumab 120 mg
Placebo 16 weeks and ligelizumab 120 mg/240 mg
Placebo 8 weeks and ligelizumab 240 mg
ligelizumab 240 mg subcutaneous injection for 52 weeks
ligelizumab 120 mg subcutaneous injection for 52 weeks
Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks
Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks