ligelizumab (QGE031) / Novartis - LARVOL DELTA

Long-Term Efficacy and Safety of Ligelizumab as Re-Treatment in Patients With Chronic Spontaneous Urticaria. (PubMed, Allergy) - "Long-term and re-treatment with ligelizumab was well tolerated and efficacious in patients with CSU, aligning with the short-term outcomes observed in the Phase 3 PEARL studies."

Journal • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pediatrics • Urticaria • ARL2

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. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Our findings suggest that Ligelizumab, at doses 72 and 120 mg, might be able to improve the symptoms of CSU evidenced by the improvements in ISS7 UAS7 and UAS7 response rate and the overall quality of life with an acceptable safety profile with certain concerns regarding Ligelizumab 120 mg causing upper respiratory tract infections. However, the small number of studies included limit the generalizability of our results."

Journal • Retrospective data • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Infectious Disease • Respiratory Diseases • Urticaria

High-affinity omalizumab variants with optimized disruptive potency prevent anaphylaxis in vivo. (PubMed, J Allergy Clin Immunol) - "These findings underscore the importance of engineering next-generation anti-IgE therapies with higher affinity and disruptive potency to optimize current treatment approaches."

Journal • Preclinical

Addressing the Unmet Need in Chronic Spontaneous Urticaria: A Network Meta-Analysis of Novel and Established Therapies (EADV 2025) - "Interventions: Oral agents: Cyclosporine, fenebrutinib, hydroxychloroquine, methotrexate, remibrutinib. Subcutaneous agents: Barzolvolimab, benralizumab, dupilumab, ligelizumab, omalizumab, quilizumab, tezepelumab...Efficacy: i. All treatments except benralizumab, methotrexate, and quilizumab significantly improved UAS7, ISS7, HSS7, and DLQI vs. placebo... 1. Barzolvolimab is the most effective therapy for symptom control (UAS7/HSS7/ISS7). 2."

Retrospective data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Model-Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "In this manuscript, we provide an overview of the key modeling and simulation analyses that were part of the MIDD approach for the development of ligelizumab in CSU and how they were staggered around the availability of interim and final data from the Phase 2 and Phase 3 studies. Furthermore, we present details of the non-linear mixed-effects models characterizing the population pharmacokinetics and exposure-response relationship of ligelizumab for efficacy in adolescent and adult patients with CSU."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pediatrics • Urticaria

Biologic and small molecule therapies in chronic spontaneous urticaria: an update. (PubMed, Curr Opin Allergy Clin Immunol) - "The rapid increase in clinical trials in the field of CSU has already led to a significant improvement in treatment options beyond anti-IgE therapy with omalizumab in Japan and the USA, and further approvals of biologics and small molecules are expected shortly. It is expected that with a wider range of different approved therapeutic approaches, the treatment of CSU will have to be tailored to the urticaria subtype or patient profile in the future."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Ligelizumab use for chronic spontaneous urticaria. (PubMed, Lancet) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Ligelizumab use for chronic spontaneous urticaria - Authors' reply. (PubMed, Lancet) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

LP-003 Significantly Decreases CSU Disease Activity and is Well Tolerated: Top Line Results from a Phase 2 Trial (EAACI 2025) - "A novel anti-IgE antibody, LP-003 developed by Longbio, of even higher IgE binding affinity, stronger FcεRI inhibition and much longer half-life compared to Omalizumab and Ligelizumab, was investigated in refractory CSU patients. Conclusion These phase II results indicated that LP-003 demonstrated potentially superior improvement compared to Omalizumab in a dose-dependent manner with longer dosing intervals. LP-003 was also well tolerated with a favorable safety profile."

Late-breaking abstract • P2 data • Immunology

Structural and Functional Insights Into IgE Receptor Interactions and Disruptive Inhibition. (PubMed, Immunol Rev) - "Initial anti-IgE biologics, such as omalizumab, were developed to neutralize free IgE in circulation and prevent receptor binding...In this review, we highlight how an improved structural and mechanistic understanding of IgE and its receptors has guided the design of such next-generation anti-IgE molecules. Such multifunctional biologics might offer faster onset, broader activity, and potential use in acute allergic situations, setting the stage for a new era in IgE-targeted therapy."

Journal • Review • Allergy • Immunology • FCER2

Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria: A Systematic Review and Meta-analysis of Randomized Controlled Trials. (PubMed, Clin Drug Investig) - "Ligelizumab significantly improves CSU symptoms compared with placebo, reducing disease severity, itching, and hives, with similar safety to omalizumab. Ligelizumab's higher affinity for immunoglobulin E (IgE) may provide better symptom control. Limitations include a small number of studies, short follow-up periods, and patient variability."

Journal • Retrospective data • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Long-term Extension Study of Ligelizumab in Food Allergy (clinicaltrials.gov) - P3 | N=163 | Terminated | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Terminated; Sponsor decision

Trial termination • Allergy • Food Hypersensitivity • Immunology

Emerging treatments for dermatologic diseases in infants, children, and adolescents: a systematic review of clinical trials on biologics and small molecule inhibitors. (PubMed, Inflammopharmacology) - "Biologics and SMIs show great promise as therapeutic options in paediatric dermatology, offering better efficacy compared to traditional treatments. Despite these encouraging findings, additional research is needed to verify their long-term safety, especially in relation to growth and development in younger patients. Future investigations should aim to include a broader range of patient demographics and dermatological conditions beyond those currently studied."

Journal • Review • Alopecia • ANCA Vasculitis • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Psoriasis • Urticaria • Vasculitis

From wheal to wellness: efficacy and safety of ligelizumab in chronic spontaneous urticaria: a systematic review and meta-analysis. (PubMed, Arch Dermatol Res) - "No significant adverse effects were reported with ligelizumab 72 mg, but very mild adverse effects were discovered with the 120 mg dose. Ligelizumab, at doses of 72 mg and 120 mg, effectively manages CSU by reducing symptoms and improving overall quality of life compared to placebo, although 120 mg Ligelizumab is associated with mild Adverse Events."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU (AAAAI-WAO 2025) - "A new anti-IgE antibody, LP-003 developed by Longbio, of even higher IgE binding affinity, stronger FcεRI inhibition and much longer half-life compared to Omalizumab and Ligelizumab, was investigated in refractory CSU patients. Conclusions These interim-analysis results indicated that 200mg Q4W and 200mg Q8W LP-003 demonstrated potentially superior improvement and 100 mg Q8W LP-003 shows non-inferiority compared to Omalizumab group. LP-003 was also well-tolerated with a favorable safety profile."

P2 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Long-term Extension Study of Ligelizumab in Food Allergy (clinicaltrials.gov) - P3 | N=165 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | N=550 ➔ 165

Enrollment change • Allergy • Food Hypersensitivity • Immunology

Long-term Extension Study of Ligelizumab in Food Allergy (clinicaltrials.gov) - P3 | N=550 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jul 2029 ➔ Feb 2025 | Trial primary completion date: Jul 2029 ➔ Feb 2025

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy (clinicaltrials.gov) - P3 | N=211 | Terminated | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Aug 2023 ➔ Nov 2023

Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria. (PubMed, Allergol Int) - "Treatment with ligelizumab 120 mg was well-tolerated with mild to moderate adverse events and was efficacious in Japanese patients."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Long-term Extension Study of Ligelizumab in Food Allergy (clinicaltrials.gov) - P3 | N=550 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2027 ➔ Jul 2029 | Trial primary completion date: Jul 2027 ➔ Jul 2029

Enrollment closed • Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Time-course and dose-effect of omalizumab in treating chronic idiopathic urticaria/chronic spontaneous urticaria. (PubMed, Eur J Clin Pharmacol) - "Omalizumab showed a significant dose-dependent effect in the treatment of CSU. Both 72 mg and 120 mg ligelizumab might have the potential to outperform 150 mg (but not 300 mg) omalizumab."

Journal • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • ARL2

Characterization of anti-IgE molecules to inhibit IgE:receptor interactions and suppress IgE production in B-cells (EAACI 2024) - "Interestingly, KIH_E07_79 suppressed IgE production in a similar range as previously described for the anti-IgE antibody ligelizumab and reduced the number of IgE+ cells in primary human B-cells in vitro comparable to the anti-IgE antibody quilizumab...In addition to active desensitization of allergic effector cells, KIH_E07_79 also inhibits IgE production and reduces IgE+ cells in primary human B-cell cultures. These additional modes-of-action could potentially be of clinical relevance and might increase the efficacy of such a multi-level IgE targeting approach."

Allergy • Immunology • FCER2 • IL4

Biologic therapy for chronic spontaneous urticaria in pediatrics and adolescents: current landscape, challenges, and future perspectives. (PubMed, Expert Opin Biol Ther) - "Ligelizumab, a next-generation anti-IgE mAb, showed effectiveness in adults but lacks pediatric studies. CT-P39, a biosimilar to omalizumab, demonstrates promise, yet adolescent-specific outcomes are undisclosed. Dupilumab's recent approval for atopic dermatitis in children from 6 months onwards signifies progress...Despite challenges, the biology therapy outlook for pediatric and adolescent CSU is promising. Importantly, studies indicate that pediatric CSU is at least as prevalent as in adults, highlighting the need for approved treatments in this population."

Journal • Review • Asthma • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Pediatrics • Pulmonary Disease • Respiratory Diseases • Urticaria

Long-term Extension Study of Ligelizumab in Food Allergy (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Feb 2031 ➔ Jun 2027 | Trial primary completion date: Oct 2030 ➔ Jun 2027

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

New biologics for food allergy. (PubMed, Curr Opin Allergy Clin Immunol) - "Biologics hold promising potential for food allergy treatment. Tailoring therapeutic approaches based on shared decision-making becomes pivotal. While omalizumab remains a significant option, next-generation anti-IgE antibodies and agents targeting alarmins exhibit unique strengths. Dupilumab, despite limited success as monotherapy, shows promise as an adjunct for OIT. Careful consideration of treatment goals, patient preferences, and the evolving landscape of biologics will shape future clinical practice, offering allergists an expanded toolbox for personalized food allergy management."

Journal • Allergy • Food Hypersensitivity • Immunology • IL33 • IL4 • IL4R