Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy

Inclusion Criteria:

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), ≥ 0.35 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. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
6. Participants must weigh ≥ 20 kg at Screening 1.

Exclusion Criteria:

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:
4. FEV1 <80% of subject's predicted normal value at Screening visit 1
5. One hospitalization for asthma within 12 months prior to Screening visit 1

Other protocol-defined inclusion/exclusion criteria may apply.