Clinical Trials

This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.

The purpose of this extension study is to evaluate the long-term safety of QGE031 when given to patients with chronic spontaneous urticaria who completed the previous study CQGE031C2201.

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

The purpose of this study is to establish effectivess and safety of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU), or Hives, who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab. The study population will consist of approximately 1050 male and female subjects aged ≥ 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study. This is a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period ...

The purpose of this study is to establish effectiveness and safety of ligelizumab. This will be assessed in patients with chronic spontaneous urticaria (CSU) who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. For this curreent study only adults will be enrolled, as no adolescents were enrolled in the previous study (CQGE031C2303).  In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed.  This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or ...

The purpose of this study is to establish the effectiveness, safety, and tolerability of remibrutinib (LOU064) 25 mg b.i.d. in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

The goal is to assess the criterion and predictive validity of the diagnostic criteria for anaphylaxis proposed by the 2nd Symposium on the Definition and Management of Anaphylaxis. Determination of the clinical utility of the diagnostic criteria is essential for the criteria to be widely adopted into clinical practice.  Prospectively, the NIAID/FAAN criteria continued to be highly sensitive (95%) but had lower specificity (71%) than on retrospective assessment. These criteria are likely to be useful for the diagnosis of anaphylaxis in the ED.

The aim of this study is to examine the role of mast cell mediators in children with allergic disorders in a two part study. Part 1 of the study will prospectively obtain the values of mast cell mediators, including 2,3 dinor 11β-PGF2α, n-MH, and LTE4 in the urine of a healthy pediatric reference population. Part 2 of the study will prospectively evaluate the urine concentrations of mast cell mediators in a cohort of pediatric allergic disorder patients including asthma, allergic rhinoconjunctivitis, eczema, urticaria, systemic anaphylaxis, and mast cell disorders, as well as POTS (postural orthostatic tachycardia syndrome). Comparisons of these ...