STRATOS 1 and 2: considerations in clinical trial design for a fully human monoclonal antibody in severe asthma

New therapies are being developed to target proinflammatory mediators thought to be involved in the pathophysiology of severe asthma. Tralokinumab is an investigational fully human monoclonal antibody that specifically blocks binding of IL-13 to its receptors. Here, we describe the background leading to the design of two Phase III trials, STRATOS 1 and 2 (NCT02161757 and NCT02194699), which aim to provide confirmatory evidence of the efficacy and safety of tralokinumab in patients with asthma that is uncontrolled despite treatment with inhaled corticosteroids and long-acting β2-agonists. These trials will also confirm the validity of periostin and DPP-4, identified in a prior Phase IIb study (NCT01402986), as predictors of an enhanced response to tralokinumab.