peanut allergy Food allergy, peanut allergy, oral food challenge, IgE, ligelizumab
Conditions
Interventions
Drug: ligelizumab
Subcutaneous injection once every 4 weeks
Drug: Placebo
Subcutaneous injection once every 4 weeks
Sponsors
Maruyama Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants who are >= 6 and == 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 == 20 kg at Screening 1.
Exclusion criteria
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: - FEV1 <80% of subject's predicted normal value at Screening visit 1 - One hospitalization for asthma within 12 months prior to Screening visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who can tolerate a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12. Responder status is defined as tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12 | — |
Countries
Australia, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed