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

Summary

This was 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) SC q4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of Immunoglobulin E (IgE) mediated peanut allergy.

Timeline

Start

2021-12-07

Primary completion

2023-11-27

Completion

2023-11-27

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped: “Study terminated by sponsor”

registry analysis (other test); Ligelizumab 240 mg vs Placebo; p = 0.002; Odds Ratio (OR) 25.83 (95% CI 4.34 to 506.78); Regression, Logistic NCT04984876 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ligelizumab	Monoclonal antibody	120 mg	Subcutaneous
Subject	Ligelizumab	Monoclonal antibody	240 mg	Subcutaneous

Indications