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Ligelizumab for Chronic Spontaneous Urticaria
Marcus Maurer1, Ana M Giménez-Arnau1, Gordon Sussman1
1From the Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin (M. Maurer, M. Metz), the Department of Dermatology, University Allergy Center, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden (A. Bauer), the Department of Dermatology, University Hospital Münster, Münster (R.B.), the Department of Dermatology, University Medical Center Mainz, Mainz (P.S.), and the Department of Dermatology and Allergy, Comprehensive Allergy Center, Hannover Medical School, Hannover (B.W.) - all in Germany; the Dermatology Department, Hospital del Mar-Institut Hospital del Mar d'Investigacions Mèdiques, Universitat Autònoma Barcelona, Barcelona (A.M.G.-A.); the Division of Allergy and Clinical Immunology, St. Michael's Hospital and University of Toronto, Toronto (G.S.), Service d'Allergie, Centre Hospitalier Université Laval-Centre Hospitalier Universitaire de Québec, Quebec, QC (J.H.), and the Department of Medicine, University of Ottawa, Ottawa (K.K.) - all in Canada; Baker Allergy Asthma and Dermatology Clinic, Portland, OR (D.R.B.); University of Cincinnati College of Medicine, Department of Internal Medicine, Division of Immunology, Rheumatology, and Allergy and Bernstein Clinical Research Center, Cincinnati (J.A.B.); the Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine (C.-Y.C.), and the Department of Dermatology, Chang Gung Memorial Hospital (W.-H.C.), Taipei, Taiwan; the National Research Center-Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow (I.D.), and the Department of Clinical Immunology and Allergology, Smolensk State Medical University, Smolensk (R.M.) - both in Russia; St. John's Institute of Dermatology, Guy's and St. Thomas' Hospitals NHS Foundation Trust, London (C.G.), and the National Institute for Health Research-Leeds Biomedical Research Centre and Leeds Institute of Rheumatic and Musculoskeletal Medicine, and the Department of Clinical Immunology and Allergy, St. James's University Hospital, Leeds (S.S.) - all in the United Kingdom; the School of Medicine, Western Sydney University, and the Immunology and Allergy Unit, Campbelltown Hospital, Campbelltown, NSW (C.K.), and Sinclair Dermatology and the Epworth Hospital, Melbourne, VIC (R.S.) - all in Australia; the Second Department of Dermatology and Venereology, Attikon University Hospital, Athens (M. Makris); Little Rock Allergy and Asthma Clinic, Little Rock, AR (K.S.); Novartis Pharma, Basel, Switzerland (J.L., T.S., R.J.); Novartis Pharmaceuticals, East Hanover, NJ (A. Barve, K.K.); and Shanghai Novartis Trading, Shanghai, China (E.H.).
Ligelizumab, a novel anti-IgE antibody, demonstrated superior efficacy in achieving complete symptom control for chronic spontaneous urticaria compared to omalizumab and placebo. Higher doses of ligelizumab showed a dose-response relationship, offering a promising new treatment option.
Area of Science:
- Immunology
- Dermatology
- Clinical Pharmacology
Background:
- Chronic spontaneous urticaria (CSU) often shows inadequate symptom control with existing therapies.
- Ligelizumab is a high-affinity humanized monoclonal anti-IgE antibody.
- Limited data exist on ligelizumab's dose-response, efficacy, and safety versus omalizumab in CSU.
Purpose of the Study:
- To determine the dose-response relationship of ligelizumab in CSU patients.
- To compare the efficacy and safety of ligelizumab against omalizumab and placebo.
- To evaluate ligelizumab's effectiveness in inadequately controlled CSU.
Main Methods:
- Phase 2b, randomized, double-blind trial involving 382 patients.
- Patients received ligelizumab (24mg, 72mg, 240mg), omalizumab (300mg), or placebo subcutaneously every 4 weeks for 20 weeks.
- Primary endpoint: complete hive control at week 12, assessed by weekly hive-severity scores.
Main Results:
- At week 12, complete hive control was achieved in 30% (24mg), 51% (72mg), and 42% (240mg) of ligelizumab groups, versus 26% (omalizumab) and 0% (placebo).
- A clear dose-response relationship for ligelizumab was established.
- No significant safety concerns were identified for ligelizumab or omalizumab.
Conclusions:
- Ligelizumab, particularly at 72mg and 240mg doses, demonstrated a higher percentage of complete symptom control in CSU patients than omalizumab or placebo.
- The study establishes a dose-response relationship for ligelizumab.
- Ligelizumab presents a potentially more effective therapeutic option for CSU management.
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