17 results
Primary ObjectiveThe primary objective is to investigate the PK of the MMF * the main metabolite of DMF * following administration of a delayed-and slow-release tablet formulation (FP187-GC) and the marketed enteric-coated delayed release…
Primary:To evaluate whether patients with severe eosinophilic asthma who have received longterm treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit.Secondary:To assess the safety…
Primary:To describe in a pragmatic setting whether there is an improvement in asthma control from the beginning to the end of the study,when directly switched to mepolizumab, in subjects with a severe eosinophilic asthma phenotype not optimally…
North America, Europe, and rest of worldThe primary objective of this study is to determine whether BG00012, when compared with placebo, is effective in reducing the proportion of relapsing subjects at 2 years.The secondary objectives of this study…
Primary: To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS).Secondary: Safety, tolerability, other efficacy parameters, quality of life.
Primary: To collect long term safety data.Secondary: To collect data on long term asthma control.
With this project we aim to determine the efficacy of anti-IL-5 treatment (mepolizumab) on virus-induced exacerbations in allergic asthma patients.Specific research questionsDoes IL-5 neutralisation:1) reduce the inflammatory response (T cell…
Primary Objective:The primary objectives of the study are to demonstrate:• Superiority of LAS41008 versus placebo based on the proportion of subjects achievingPASI 75 at week 16 (a 75% reduction in the Psoriasis Area and Severity Index, PASI,…
The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible asthma subjects who previously participated in a GSK-sponsored mepolizumab study. During the execution of the protocol SAEs…
Primary: To evaluate the long-term safety profile of BG00012.Additional: To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and annualized relapse rate [ARR]) and disability progression (Expanded Disability…
Primary Objective:To compare the Cross Clamp Time collected with EDWARDS INTUITY Elite to published data with a conventional valve within a MIS approachSecondary Objectives:To describe short term (30 days) and long term (6 months) clinical safetyTo…
Objective: The objective of the study is establish the half-life of eosinophils in blood and sputum and determination of the effect of Nucala® hereon.
Primary:To assess the use of mepolizumab in safety syringe for the subcutaneous self-administration of mepolizumab by subjects with severe eosinophilic asthma.Secondary:To assess the use of mepolizumab in safety syringe outside the clinic setting.…
Primary:To evaluate the efficacy of 100mg mepolizumab compared to placebo.Secondary:The impact on actual nasal surgery. Further efficacy assessment. Quality of life.
Primary: To evaluate the efficacy and safety of mepolizumab 100 mg and 300 mg subcutaneous given every 4 weeks compared to placebo on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations despite the use…
Primary: To provide extended treatment with mepolizumab to subjects with severe asthma and a history of improved disease control while receiving mepolizumab as defined by this protocol.Secondary: To collect data on long term clinical data.
Primary: To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) every 4 weeks versus placebo on health-related quality of life (HR-QoL) in adult and adolescent subjects with severe eosinophilic asthma. Secondary: To assess the effects of…