ligelizumab   Click here for help

GtoPdb Ligand ID: 8997

Synonyms: CL-2C | NVP-QGE031 | QGE031
Immunopharmacology Ligand
Compound class: Antibody
Comment: Ligelizumab is a humanized, investigational high-affinity anti-IgE monoclonal antibody with anti-inflammatory potential [1], with improved pharmacokinetics and clinical effects compared to omalizumab.
Peptide sequences for this antibody are available from its IMGT/mAb-DB record.
BLAST peptide sequence analysis reveals identical matches with antibody sequences claimed in patent US7531169 B2, where it is the clone designated as CL-2C [3].
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No information available.
Summary of Clinical Use Click here for help
Several Phase 2 clinical trials were underway to evaluate the potential of QGE031 as a treatment for asthma and chronic spontaneous urticaria [2]. As of May 2021, the asthma studies had been terminated, duw to alck of efficacy. Ligelizumab failed to demonstrate superiority over placebo or omalizumab [4]. Evaluation in chronic urticaria has progressed to Phase 3.
Mechanism Of Action and Pharmacodynamic Effects Click here for help
IgE acts as an environmental sensor facilitating an immune response via the high-affinity IgE receptor, FcεRI. This action sensitizes mast cells to specific antigens which, upon allergen exposure, release pro-inflammatory cytokines and other mediators of the allergic response. Ligelizumab is designed to bind to circulating IgE, thereby reducing IgE-mediated responses.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT01716754 Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma Phase 2 Interventional Novartis 4
NCT03907878 A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines Phase 3 Interventional Novartis
NCT04210843 Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab Phase 3 Interventional Novartis