Trial reportClinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology2014
Pharmacokinetics, pharmacodynamics and safety of QGE031 (ligelizumab), a novel high-affinity anti-IgE antibody, in atopic subjects.
Trial report in Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 99 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
99 citing papers in PubMed, 3 syntheses or guidelines pooled it, 240 citations in OpenAlex.
- Efficacy and safety of different doses of ligelizumab in patients with chronic spontaneous urticaria: a systematic review and meta-analysis of randomized controlled trials with GRADE evaluation.Naunyn-Schmiedeberg's archives of pharmacology · 2026Pooled it
- Time-course and dose-effect of omalizumab in treating chronic idiopathic urticaria/chronic spontaneous urticaria.European journal of clinical pharmacology · 2024Pooled it
- Systemic treatments for eczema: a network meta-analysis.The Cochrane database of systematic reviews · 2020Pooled it
- Long-Term Efficacy and Safety of Ligelizumab as Re-Treatment in Patients With Chronic Spontaneous Urticaria.Allergy · 2026Trial
- Ligelizumab Immunogenicity and Impact on Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety in Patients With Chronic Spontaneous Urticaria.Clinical and translational science · 2026Trial
- Pharmacokinetics, pharmacodynamics and safety of QGE031 (ligelizumab), a novel high-affinity anti-IgE antibody, in atopic subjects.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2014Trial
- Management of Pediatric Chronic Spontaneous Urticaria: Current Evidence and Emerging Therapies.Paediatric drugs · 2026Review
- Chronic Spontaneous Urticaria in the Era of Targeted Therapy: From Pathogenic Mechanisms to Precision Medicine.Pharmaceutics · 2026Review
- Therapeutic Applications of Immunobiologics in Autoimmune and Inflammatory Diseases.Pharmaceutics · 2026Review
- Immunological Basis of Chronic Spontaneous Urticaria: Immunoglobulin E and Beyond.Yonsei medical journal · 2026Review
- Emerging IgE and non-IgE targeted therapies for chronic urticaria.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2026Review
- Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond.The journal of allergy and clinical immunology. In practice · 2026Review
- Model-Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria.CPT: pharmacometrics & systems pharmacology · 2025Article
- Recombinant BCG Expressing IL-12 as A Novel Immunomodulatory Strategy for Allergic Asthma: Opportunities and Challenges.Clinical reviews in allergy & immunology · 2025Review
- Structural and Functional Insights Into IgE Receptor Interactions and Disruptive Inhibition.Immunological reviews · 2025Review
- LuLIPLEX: A Fast, Highly Sensitive, and Multiplexed Method for the Detection of IgE Against Major Allergens.Allergy · 2025Article
- Emerging diagnostic and therapeutic opportunities in food allergy.Frontiers in immunology · 2025Review
- IgE versus IgG and IgA: Differential roles of allergen-specific antibodies in sensitization, tolerization, and treatment of allergies.Immunological reviews · 2024Review
- The Relationship Between Asthma and Food Allergies in Children.Children (Basel, Switzerland) · 2024Review
- Peanut Allergy in Children-Is Prevention Better than Cure?Nutrients · 2024Review
39 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUsing a monoclonal antibody with greater affinity for IgE than omalizumab, we examined whether more complete suppression of IgE provided greater pharmacodynamic effects, including suppression of skin prick responses to allergen.
objectiveTo explore the pharmacokinetics, pharmacodynamics and safety of QGE031 (ligelizumab), a novel high-affinity humanized monoclonal IgG1κ anti-IgE.
methodsPreclinical assessments and two randomized, placebo-controlled, double-blind clinical trials were conducted in atopic subjects. The first trial administered single doses of QGE031 (0.1-10 mg/kg) or placebo intravenously, while the second trial administered two to four doses of QGE031 (0.2- 4 mg/kg) or placebo subcutaneously at 2-week intervals. Both trials included an open-label omalizumab arm.
resultsSixty of 73 (82%) and 96 of 110 (87%) subjects completed the intravenous and subcutaneous studies, respectively. Exposure to QGE031 and its half-life depended on the QGE031 dose and serum IgE level. QGE031 had a biexponential pharmacokinetic profile after intravenous administration and a terminal half-life of approximately 20 days. QGE031 demonstrated dose- and time-dependent suppression of free IgE, basophil FcεRI and basophil surface IgE superior in extent (free IgE and surface IgE) and duration to omalizumab. At Day 85, 6 weeks after the last dose, skin prick wheal responses to allergen were suppressed by > 95% and 41% in subjects treated subcutaneously with QGE031 (2 mg/kg) or omalizumab, respectively (P < 0.001). Urticaria was observed in QGE031- and placebo-treated subjects and was accompanied by systemic symptoms in one subject treated with 10 mg/kg intravenous QGE031. There were no serious adverse events. CONCLUSION AND CLINICAL RELEVANCE: These first clinical data for QGE031, a high-affinity IgG1κ anti-IgE, demonstrate that increased suppression of free IgE compared with omalizumab translated to superior pharmacodynamic effects in atopic subjects, including those with high IgE levels. QGE031 may therefore benefit patients unable to receive, or suboptimally treated with, omalizumab.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.