Thanai Pongdee, M.D.

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.

This purpose of this study is to evaluate TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults, compared to placebo.

The purpose of this study is to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.

The plan is to participate in Part B of the study only. 

The purpose of this study is to evaluate the effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult participants with severe asthma with an eosinophilic phenotype (SA-EP).

The purpose of this study is to evaluate the effectiveness of depemokimab 200 mg subcutaneous (SC) given every 6 months versus placebo in participants with uncontrolled Hypereosinophilic Syndrome (HES) receiving standard of care (SoC).

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

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:

1. To identify predictors of inferior overall survival in HES/IHE patients including molecular parameters using next-generation sequencing performed at the point of clinical care
2. To apply the previously proposed prognostic model that included myeloid-relevant gene mutations to identify high-risk HES/IHE patients for closer monitoring

This purpose of this study is to evaluate TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

The purpose of this study to determine recommended dose (RD) of BLU-263 for patients with Indolent Systemic Mastocytosis.

The purpose of this clinical study is to investigate the safety, tolerability, and efficacy of dexpramipexole in participants with inadequately controlled severe eosinophilic asthma.

The purpose of this study is to evaluate the rate of compliance for having an emergency epinephrine autoinjector readily accessible in adults with allergies, and to determine factors that negatively influence adults with allergies for having an emergency epinephrine autoinjector readily accessible.

A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.

The purpose of this study is to investigate the effectiveness and safety of mepolizumab in children and adolescents with hypereosinophilic syndrome (HES) who are receiving standard of care (SoC) therapy.

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 primary purpose of Part 1 of this study is to determine the Recommended Phase 2 Dose (RP2D) in patients with Indolent Systemic Mastocytosis (ISM) for use in Part 2 and Part 3 of the study.

The primary purpose of Part 2 of this study is to determine the effect of avapritinib in reducing symptoms in Indolent Systemic Mastocytosis (ISM) and Smoldering Systemic Mastocytosis (SSM) patients, as compared to placebo.

The primary purpose of Part 3 of this study is to assess the long-term safety and effectiveness of avapritinib in Indolent Systemic Mastocytosis (ISM) and Smoldering Systemic Mastocytosis (SSM) patients.

The purpose of this study is to provide a mechanism for expanded access to mepolizumab therapy for eligible patients with Hypereosinophilic Syndrome (HES).

The purpose of this study is to identify gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA), and to determine the composition of immune cells present in the microenvironment of individuals with SEA after initiation of mepolizumab.

The primary objective of this study is to determine the prevalence of KIT D816V mutation in peripheral blood (PB) of patients with evidence of systemic Mast Cell Activation (MCA).