(Novartis QGE031) A 52 week, multi-center, randomized, double-blind placebo-controlled study to assess the clinical efficacy and safety of ligelizumab (QGE0312) in decreasing the sensitivity to peanuts in patients with peanut allergy
Study ID: STU-2021-0683
Summary
This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SCq4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.
To evaluate the efficacy of ligelizumab 240mg and 120mg (SCq4w), compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >600mg of peanut protein without dose-limiting symptoms during the DBPCFC at week 12