drugset / Trial / NCT04984876

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

NCT04984876

Phase 3 Terminated 211 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Ligelizumab Monoclonal antibody 120 mg Subcutaneous
Subject Ligelizumab Monoclonal antibody 240 mg Subcutaneous

Indications