Clinical Trials

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 develop a registry to collect long-term data on patients with pediatric cutaneous mastocytosis, and develop better knowledge of the timing, symptoms, resolution or progression of the disease, and predictive markers of its severity.

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 purpose of this study is to evaluate the safety and effectiveness of repeated subcutaneous (SC) administrations of Lanadelumab in preventing angioedema attacks in adolescents and adults with non-histaminergic angioedema with normal C1-INH and in adults with acquired angioedema (AAE) due to C1-INH deficiency.

The purpose of this study is to evaluate the long-term safety and effectiveness of repeated subcutaneous (SC) administration of lanadelumab in adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303.

The purpose of this study is to evaluate the long-term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angiodema (HAE).

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.