Clinical Trials

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to prior stable HES background therapy, and an open-label (OLE) treatment period, during which all patients will receive benralizumab. The primary database lock (DBL) will occur when at least 47 patients have had their first HES worsening/flare event and all randomised patients have been followed up for the 24-week DB treatment period. The target patient population is male and female patients 12 years of age and older with symptomatic active HES. Approximately 120 eligible patients will be randomised at a 1:1 ratio to receive either benralizumab or matching placebo.

Allergic and immunologic disorders are very common but some are very poorly understood. Numerous studies of the epidemiology, characteristics, diagnosis and treatment of these disorders are urgently needed to identify and optimally treat affected patients. Though numerous challenges impact the progress of research in this area, specimens are needed to test new hypotheses and methodologies.  We aim to create a registry and biorepository of tissue and fluid specimens for future studies.

This study is being done in order to gain a greater understanding of rhinitis and sinusitis conditions and to improve diagnostic and treatment options for these conditions.

The purpose of this study is to build a National Registry of individuals with one of the group of primary immune deficiency diseases. A "Registry" is a list of basic information about people who have a certain disease or condition in common. These immune deficiency diseases are thought to be rare and include: Severe combined immunodeficiency (SCID), leukocyte adhesion deficiency (LAD), X-linked Agammaglobulinemia (XLA), common variable immune deficiency (CVID), DiGeorge syndrome (DGS), Hyper IgM syndrome (HIGM), Wiskott Aldrich syndrome (WAS) and chronic granulomatous disease (CGD). We would like to contribute data on a number of subjects with these relatively rare diseases to this National Registry Data Base. The information will be age, sex, race or ethnic group, immunologic lab tests that were used to diagnose the condition, what complications may have occurred since the condition started, lung disease, blood changes, etc. and the results of various treatments used. The goal is to discover basic outcome data, ethnic, racial characteristics, kind of complications and useful treatments. You will not be contacted by anyone unless you authorize it. If a new study about you (or your child’s) immune defect comes up, your doctor will be notified, who can then share this with you to find out if you are interested in participating or not. Alternatively you may elect to be contacted directly by the Registry to determine your interest in participation.

The purpose of this study is to compare the assessment of the composition of the fecal, nasal,oral and skin microbiota in patients with AD (cases) as compared to age/sex and diet matched control children without atopic dermatitis, and to apply mass-spectrometry-based metabolomic approach to analyzing fecal, nasal, oral and skin samples from cases, in order to characterize their biochemical metabolic profiles by comparison with those of their controls.

The purpose of this study is to evaluate the contribution of C. albicans to dysbiotic microbial communities of mucosal tissues in pediatric populations. Prospective sampling across multiples tissue sites in a pediatric cohort will be used to assess which tissues are colonized by C. albicans and associated with microbial dysbiosis seen in atopic dermitis.

We hypothesize presence of C. albicans in the microbial communities in early life is associated with atopy. We will assess the presence of C. albicans in the microbial communities of a population of children at-risk for atopic dermatitis compared to healthy controls who do not have an underlying risk for atopy based off family history. In tandem with the collection of human samples, we will utilize mouse models to validate the influence of C. albicans exposure during early life on the systemic immune populations.

The purpose of this study is to identify biomarkers that can show differences in mast cell disease (Mastocytosis) status and activity for help with diagnosis and prognosis.

The purpose of this study is to build a Mayo Clinic registry of data and biobank from subjects with drug allergy. The data collected will include demographic, diagnostic, and health data on a large group of patients to discover novel drug allergy diagnostic methods.

The purpose of this study is to characterize the immunophenotype of individuals with hypereosinophilia-associated cardiovascular, gastrointestinal, hematologic, and respiratory disorders.

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 values in the disease cohort will be made utilizing the pediatric expected reference intervals established in Part 1. Further analysis will determine if one or several urine mast cell mediators are elevated in a particular allergic disorder.