0000000000341328
AUTHOR
Richard Leigh
showing 3 related works from this author
Late Breaking Abstract - Efficacy of CSJ117 on allergen-induced asthmatic responses in mild atopic asthma patients
2020
Introduction: CSJ117 is a potent neutralizing antibody fragment against human Thymic stromal lymphopoietin (TSLP), formulated as a PulmoSol™ engineered powder in hard capsules for delivery to the lungs via dry powder inhaler. Methods: In this double-blind, placebo-controlled study, 28 mild, atopic asthmatics meeting elibility criteria were randomized to receive 4mg CSJ117 (n = 15) or placebo (n = 13) inhaled daily for 12 weeks. Allergen inhalation challenge (AIC) was conducted at screening, day 42 and day 84. The primary efficacy variable was the late asthmatic response (LAR), measured 3 to 7 hours after AIC at day 84. Other outcomes included the early asthmatic response (EAR) measured with…
Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma
2018
Background Mepolizumab has demonstrated favorable safety and efficacy profiles in placebo-controlled trials of 12 months' duration or less; however, long-term data are lacking. Objective We sought to evaluate the long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma (SEA). Methods COLUMBA (Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects, NCT01691859 ) was an open-label extension study in patients with SEA previously enrolled in DREAM (Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma, NCT01000506 ). Patients received 100 mg of subcutaneous mepolizumab every 4 weeks plus standard of care until a protocol-def…
Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial
2015
Summary Background Interleukin 13 is a central mediator of asthma. Tralokinumab is a human interleukin-13 neutralising monoclonal antibody. We aimed to assess the efficacy and safety of two dosing regimens of tralokinumab in patients with severe uncontrolled asthma. Methods We did a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 2b study at 98 sites in North America, South America, Europe, and Asia. Patients aged 18–75 years with severe asthma and two to six exacerbations in the previous year were randomly assigned (1:1), via an interactive voice-response or web-response system, to one of two dosing regimen groups (every 2 weeks, or every 2 weeks for 12 wee…